Home › Device types › IZF
System, X-Ray, Tomographic
FDA product code IZF · Class 2 · Radiology
14
Registered devices
44
Adverse events
6
Recalls
42
510(k) clearances
Devices with this code
Discovery RF180 — GENERAL MEDICAL MERATE SPADR-ID 900MC — FUJIFILM CORPORATIONTAP2D — NANO-X IMAGING LTDDR-ID 900MC — FUJIFILM CORPORATIONDefinium — GE Hualun Medical Systems Co., LtdCLISIS SYSTEMS — GENERAL MEDICAL MERATE SPADR-ID 900MC — FUJIFILM CORPORATIONNanox.ARC — NANO-X IMAGING LTDDiscovery — GE Hualun Medical Systems Co., LtdDR-ID 900MC — FUJIFILM CORPORATIONAdaptix Ortho350 — ADAPTIX LIMITEDDiscovery — GE Hualun Medical Systems Co., LtdNanox.ARC X — NANO-X IMAGING LTDDefinium — GE Hualun Medical Systems Co., Ltd
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-18 | AGFA Healthcare Corp. | It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on th |
| 2020-02-10 | Agfa N.V. | Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures. |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fa |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fa |
| 2018-07-16 | Philips Electronics North America Corporation | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fa |
| 2003-04-15 | Siemens Medical Solutions USA, Inc | the back up safety catch may not function properly |
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