FDA product code · Radiology
JAKSystem, X-Ray, Tomography, Computed
Product code JAK covers System, X-Ray, Tomography, Computed, a Class II device regulated under 21 CFR 892.1750. FDA has cleared 821 devices in this code, 22 of them in the last 12 months. Median review time across the 821 most recent decisions is 86 days. openFDA lists 860 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1750
- Review panel
- Radiology
- Clearances
- 821
What is happening in JAK right now?
JAK (System, X-Ray, Tomography, Computed) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2650-2026, Z-2651-2026, Z-2652-2026, Z-2149-2026, Z-2150-2026). 1 first-time filer in the last 12 months, Mars Bioimaging , Ltd (K252249). Clearances are running 48% slower — a median 127 days over the last 12 months against 86 days all-time (elapsed calendar days, not FDA review days) (JAK:review_time:12m). The code is crowded, scoring 86 of 100 — 185 companies hold a clearance here and 22 arrived in the last 12 months (JAK:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2650-2026, Z-2651-2026, Z-2652-2026, Z-2149-2026, Z-2150-2026 |
| New entrant | Worth knowing | K252249 |
| Review time | Context | JAK:review_time:12m |
| Crowding | Context | JAK: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 JAK?
FDA has cleared 821 devices under product code JAK since the 510(k) programme began in 1976, 22 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253770 | CardIQ Suite | GE Medical Systems SCS | |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation |
How long does FDA review take for JAK?
The median FDA review time for JAK is 86 days, measured across the 821 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 JAK?
openFDA lists 860 recall records against product code JAK. A recall record covers one firm's corrective action and may span many device lots.
Z-2650-2026Open, ClassifiedPhilips Medical Systems, Inc.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Z-2651-2026Open, ClassifiedPhilips Medical Systems, Inc.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Z-2652-2026Open, ClassifiedPhilips Medical Systems, Inc.
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.
Z-2149-2026Open, ClassifiedGE Medical Systems, LLC
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Z-2150-2026Open, ClassifiedGE Medical Systems, LLC
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Showing the 5 most recently initiated of 860. 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 JAK?
MAUDE holds 714 adverse-event reports naming product code JAK, 130 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 JAK unusual?
Every month with enough history behind it falls inside JAK's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 9 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 73 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 17 | 2–32 | Within expected (2–32) | |
| 15 | 3–27 | Within expected (3–27) | |
| 24 | 4–29 | Within expected (4–29) | |
| 18 | 6–33 | Within expected (6–33) | |
| 20 | 5–30 | Within expected (5–30) | |
| 14 | 6–33 | Within expected (6–33) | |
| 15 | 13–42 | Within expected (13–42) | |
| 16 | 6–30 | Within expected (6–30) | |
| 16 | 6–30 | Within expected (6–30) | |
| 26 | 8–27 | Within expected (8–27) | |
| 14 | 9–27 | Within expected (9–27) | |
| 18 | 8–29 | Within expected (8–29) | |
| 14 | 9–33 | Within expected (9–33) | |
| 19 | 5–27 | Within expected (5–27) | |
| 13 | 7–31 | Within expected (7–31) |
21 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 JAK.
Who has entered JAK in the last year?
One company filed in JAK for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Mars Bioimaging , Ltd. | K252249 |
"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 JAK?
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 JAK?
Across the 821 most recent decisions, these applicants filed most often in JAK.
| Applicant | Recent clearances |
|---|---|
| Siemens Medical Solutions USA, Inc. | 105 |
| Toshiba America Medical Systems, In.C | 35 |
| General Electric Co. | 31 |
| Ge Medical Systems, LLC | 30 |
| Toshibamedical Systems Corporation | 27 |
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 JAK 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 | 68 | 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 JAK
Get an email the morning anything changes in JAK — 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.