Home › Device types › JAA
System, X-Ray, Fluoroscopic, Image-Intensified
FDA product code JAA · Class 2 · Radiology
1,427
Registered devices
90,606
Adverse events
223
Recalls
300
510(k) clearances
Devices with this code
PREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLCAzurion — Philips Medical Systems Nederland B.V.N23 CCD System — NICAL SPA0909FCC — Rayence Co., Ltd.IA-12LM13 — SHIMADZU CORPORATIONPREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLCUNBRANDED — ADVANCE MEDICAL DESIGNS, INC.PREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLCMULTIPURPOSE REMOTE CONTROL R/F SYSTEM — CANON INC.STEPHANIX — STEPHANIXUNBRANDED — ADVANCE MEDICAL DESIGNS, INC.Snap Kover — ADVANCE MEDICAL DESIGNS, INC.Ziehm Solo FD — Ziehm Imaging GmbHUNBRANDED — ADVANCE MEDICAL DESIGNS, INC.PULSE — Nuvasive, Inc.UNBRANDED — ADVANCE MEDICAL DESIGNS, INC.LessRay — Nuvasive, Inc.PREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLCCamera Drape — ADVANCE MEDICAL DESIGNS, INC.InfiMed Nexus, RF/DR, Non Varian Digital Receptor — INFIMED, INC.PREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLCN23 CCD System — NICAL SPAPULSE — Nuvasive, Inc.PREFERRED MEDICAL PRODUCTS, LLC — PREFERRED MEDICAL PRODUCTS, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-10-27 | Philips North America | 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 |
| 2025-10-01 | Philips 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. |
| 2025-10-01 | Philips 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. |
| 2025-10-01 | Philips 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. |
| 2025-06-04 | Siemens Medical Solutions USA, Inc | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2025-06-04 | Siemens Medical Solutions USA, Inc | A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire. |
| 2024-09-06 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography |
| 2024-09-06 | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography |
| 2024-07-29 | Agfa N.V. | Potential for the front lever chain of the DR 800 table to fail. |
| 2023-12-15 | Philips North America | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.