Home › Device types › IZL
System, X-Ray, Mobile
FDA product code IZL · Class 2 · Radiology
293
Registered devices
922
Adverse events
170
Recalls
237
510(k) clearances
Devices with this code
POSKOM Co., Ltd. — Poskom Co., Ltd.EzRay M — VATECH CO., LTD.SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.SR-1260-C — SOURCE-RAY, INC.OXBox — OXOS Medical, Inc.AirRay-mini — Poskom Co., Ltd.MobileDaRt Evolution — SHIMADZU CORPORATIONHnX-PB — H&abyz Co., LtdDRGEM — DRGEM CorporationddR Cruze — Swissray Medical AGSEDECAL — SEDECALAirRay-mini — Poskom Co., Ltd.SEDECAL — SEDECALSIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.AcuityPDR — RADMEDIX, LLCSR-115-CG — SOURCE-RAY, INC.SIUI — Shantou Institute of Ultrasonic Instruments Co., Ltd.Philips — SEDECALOptima — GE Medical Systems, L.L.C.SEDECAL — SEDECALSEDECAL — SEDECALSEDECAL — SEDECALFDR AQRO — FUJIFILM CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-05 | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa |
| 2026-06-05 | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa |
| 2026-06-05 | GE Medical Systems, LLC | GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pa |
| 2026-03-27 | Micro-X Ltd. | X-Ray generator may malfunction resulting in the X-Ray being inoperable. |
| 2025-10-07 | NeuroLogica Corporation | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue. |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
| 2025-06-10 | SEDECAL SA | Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions |
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