FDA product code · Radiology
KPSSystem, Tomography, Computed, Emission
Product code KPS covers System, Tomography, Computed, Emission, a Class II device regulated under 21 CFR 892.1200. FDA has cleared 471 devices in this code, 9 of them in the last 12 months. Median review time across the 471 most recent decisions is 75 days. openFDA lists 443 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1200
- Review panel
- Radiology
- Clearances
- 471
What is happening in KPS right now?
KPS (System, Tomography, Computed, Emission) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1112-2026, Z-1045-2026, Z-1047-2026, Z-0290-2026, Z-0291-2026). 3 first-time filers in the last 12 months, including Mediso Medical Imaging Systems, Ltd. and Trustees of the University of Pennsylvania (K253844, K251401, K250170). The code is crowded, scoring 86 of 100 — 125 companies hold a clearance here and 9 arrived in the last 12 months (KPS:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1112-2026, Z-1045-2026, Z-1047-2026, Z-0290-2026, Z-0291-2026 |
| New entrant | Worth knowing | K253844, K251401, K250170 |
| Crowding | Context | KPS:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KPS?
FDA has cleared 471 devices under product code KPS since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | |
| K250170 | PHAROS | Brightonix Imaging | |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. |
How long does FDA review take for KPS?
The median FDA review time for KPS is 75 days, measured across the 471 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KPS?
openFDA lists 443 recall records against product code KPS. A recall record covers one firm's corrective action and may span many device lots.
Z-1112-2026Open, ClassifiedGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
Z-1045-2026Open, ClassifiedGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Z-1047-2026Open, ClassifiedGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
Z-0290-2026Open, ClassifiedGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Z-0291-2026Open, ClassifiedGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Showing the 5 most recently initiated of 443. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KPS?
MAUDE holds 76 adverse-event reports naming product code KPS, 7 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KPS unusual?
One month sits above KPS's own expected range: 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 9 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 13 | 0–6 | Above expected (0–6) | |
| 3 | 0–14 | Within expected (0–14) | |
| 1 | 0–14 | Within expected (0–14) | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
27 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KPS.
Who has entered KPS in the last year?
3 companies filed in KPS for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Mediso Medical Imaging Systems, Ltd. | K253844 | |
| Trustees of the University of Pennsylvania | K251401 | |
| BRIGHTONIX IMAGING INC. | K250170 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KPS?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KPS?
Across the 471 most recent decisions, these applicants filed most often in KPS.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 46 |
| Adac Laboratories | 35 |
| Philips Medical Systems (Cleveland), Inc. | 20 |
| Cti Pet Systems, Inc. | 18 |
| GE Medical Systems | 17 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in KPS files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| GE Medical Systems, LLC | 27 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KPS
Get an email the morning anything changes in KPS — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.