Home › Device types › OAS
X-Ray, Tomography, Computed, Dental
FDA product code OAS · Class 2 · Radiology
499
Registered devices
8
Adverse events
7
Recalls
136
510(k) clearances
Devices with this code
RAYSCAN α+ — Ray Co., LtdRAYSCAN α+ — Ray Co., LtdORTHOPANTOMOGRAPH OP 3D — PaloDEx Group OyPaX-i3D Smart — VATECH CO., LTD.Dental CT Scanner AXR — Alliage S/A Indústrias Médico OdontológicaSCAN CEPH — CARESTREAM HEALTH, INC.CS 8100SC 3D — CARESTREAM DENTAL LLCRAYSCAN Studio — Ray Co., Ltdi-CAT FLX™ imaging system — Dental Imaging Technologies CorporationRAYSCAN α+ — Ray Co., LtdX-MIND trium — DE GÖTZEN SRLX-MIND prime — VILLA SISTEMI MEDICALI SPAPaX-i3D Green — VATECH CO., LTD.PaX-i3D Smart — VATECH CO., LTD.RAYSCAN a+ — Ray Co., LtdPaX-i3D Green — VATECH CO., LTD.SXR / Saevo — Alliage S/A Indústrias Médico OdontológicaSXR / Saevo — Alliage S/A Indústrias Médico OdontológicaPaX-i3D Green — VATECH CO., LTD.PaX-i3D — VATECH CO., LTD.RAYPreMiere — Ray Co., LtdORTHOPHOS XG — SIRONA Dental Systems GmbHRAYSCAN α+ — Ray Co., LtdR2 STUDIO Q — Megagen Implant Co. Ltd
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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