FDA product code · Radiology
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
Product code JAA covers System, X-Ray, Fluoroscopic, Image-Intensified, a Class II device regulated under 21 CFR 892.1650. FDA has cleared 300 devices in this code, 2 of them in the last 12 months. Median review time across the 300 most recent decisions is 67 days. openFDA lists 223 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 892.1650
- Review panel
- Radiology
- Clearances
- 300
What is happening in JAA right now?
JAA (System, X-Ray, Fluoroscopic, Image-Intensified) has three findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-0597-2026, Z-0461-2026, Z-0462-2026, Z-0463-2026). 1 first-time filer in the last 12 months, Varex Imaging Corporation (K253103). The code is crowded, scoring 72 of 100 — 152 companies hold a clearance here and 2 arrived in the last 12 months (JAA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0597-2026, Z-0461-2026, Z-0462-2026, Z-0463-2026 |
| New entrant | Worth knowing | K253103 |
| Crowding | Context | JAA: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 JAA?
FDA has cleared 300 devices under product code JAA since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253103 | Nexus DRF Digital X-ray Imaging System | Varex Imaging Corporation | |
| K251650 | Insight Enhanced DRF (EN-1002-01) | Imaging Engineering, LLC | |
| K242488 | Soteria E-View | Omega Medical Imaging, LLC | |
| K242948 | Adora DRFi (04550010) | Nrt X-Ray A/S | |
| K233380 | TRIDENT Mobile Fluoroscopy System | Dornier Medtech America | |
| K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | |
| K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | |
| K232526 | XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 | Canon Medical Systems Corporation | |
| K220871 | Nautilus | Dornier Medtech America, Inc. | |
| K212890 | Nyquist.IQ | Omega Medical Imaging, LLC |
How long does FDA review take for JAA?
The median FDA review time for JAA is 67 days, measured across the 300 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 JAA?
openFDA lists 223 recall records against product code JAA. A recall record covers one firm's corrective action and may span many device lots.
Z-0597-2026Open, ClassifiedPhilips North America LLC
Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications.
Z-0461-2026Open, ClassifiedPhilips Medical Systems DMC GmbH
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-0462-2026Open, ClassifiedPhilips Medical Systems DMC GmbH
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-0463-2026Open, ClassifiedPhilips Medical Systems DMC GmbH
Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.
Z-1981-2025Open, ClassifiedSiemens Medical Solutions USA, Inc.
A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
Showing the 5 most recently initiated of 223. 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 JAA?
MAUDE holds 97 adverse-event reports naming product code JAA, 19 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 JAA unusual?
Every month with enough history behind it falls inside JAA's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 3 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 7 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 2 | 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | 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 | |
| 3 | 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 | |
| 3 | 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 | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 4 | 1–5 | Within expected (1–5) | |
| 3 | 1–5 | Within expected (1–5) | |
| 1 | 2–5 | Below expected (2–5) | |
| 3 | 1–6 | Within expected (1–6) | |
| 1 | 1–5 | Within expected (1–5) | |
| 1 | 0–5 | Within expected (0–5) |
28 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 JAA.
Who has entered JAA in the last year?
One company filed in JAA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Varex Imaging Corporation | K253103 |
"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 JAA?
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 JAA?
Across the 300 most recent decisions, these applicants filed most often in JAA.
| Applicant | Recent clearances |
|---|---|
| Toshiba America Medical Systems, In.C | 13 |
| Fischer Imaging Corp. | 10 |
| General Electric Co. | 10 |
| Shimadzu Medical Systems | 10 |
| Siemens Medical Solutions USA, Inc. | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch JAA
Get an email the morning anything changes in JAA — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Radiology
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.