Home › Device types › OAS
X-Ray, Tomography, Computed, Dental
FDA product code OAS · Class 2 · Radiology
493
Registered devices
7
Adverse events
7
Recalls
135
510(k) clearances
Devices with this code
X-MIND trium — DE GÖTZEN SRLORTHOPANTOMOGRAPH OP 3D Pro — PaloDEx Group OyCS 8200 3D — CARESTREAM DENTAL LLCSXR / Saevo — Alliage S/A Indústrias Médico OdontológicaProVecta 3D Prime Ceph — DÜRR DENTAL SEbright MCT — Dentium Co., LtdRAYPreMiere — Ray Co., LtdGenoray — GENORAY CO., LTD.Midmark Extraoral Imaging System (EOIS) — MIDMARK CORPORATIONCS 9300C Select — CARESTREAM HEALTH, INC.RAYSCAN Studio — Ray Co., LtdCS 9300C — CARESTREAM HEALTH, INC.RAYSCAN α — Ray Co., LtdDental CT Scanner AXR — Alliage S/A Indústrias Médico OdontológicaDENTRI Max — HDX WILL CORP.i-CAT FLX™ imaging system — Dental Imaging Technologies Corporationmyray — CEFLA SOCIETA' COOPERATIVAPaX-i3D — VATECH CO., LTD.Green Smart — VATECH CO., LTD.RAYSCAN α+ — Ray Co., LtdORTHOPHOS SL — SIRONA Dental Systems GmbHi-CAT FLX™ imaging system — Dental Imaging Technologies CorporationRAYSCAN α+, Vision 16, RCT700 — Ray Co., LtdMidmark Extraoral Imaging System (EOIS) — MIDMARK CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir |
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir |
| 2025-08-26 | OSSTEM Implant Co., Ltd. | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir |
| 2021-10-28 | Palodex Group Oy | It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not |
| 2021-07-21 | Trophy SAS | Device failed to function as intended and/or failed to conform to their design specifications. |
| 2018-12-31 | KaVo Dental Technologies LLC | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 |
| 2015-08-05 | Villa Radiology Systems LLC | It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.3 |
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