FDA product code OAS: X-Ray, Tomography, Computed, Dental
OAS is the FDA product code for x-ray, tomography, computed, dental. It is a Class II device, regulated under 21 CFR 892.1750 and reviewed by the Radiology panel. FDA has cleared 131 510(k) submissions under OAS, 35 in the last five years, from 44 different applicants. The average 510(k) review took 137 days (median 113); 129 days on average over the last three years. FDA has posted 7 recalls for OAS devices, 4 initiated in the last five years.
Definition
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Classification
| Field | Value |
|---|---|
| Device name | X-Ray, Tomography, Computed, Dental |
| Device class | Class II |
| Regulation | 21 CFR 892.1750 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
510(k) clearances per year for OAS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 176 |
| 2018 | 11 | 83 |
| 2019 | 7 | 89 |
| 2020 | 9 | 103 |
| 2021 | 11 | 168 |
| 2022 | 6 | 106 |
| 2023 | 12 | 115 |
| 2024 | 4 | 142 |
| 2025 | 9 | 141 |
| 2026 | 4 | 104 |
Compare with all 510(k) review times · Search every OAS clearance
Top OAS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| VATECH Co., Ltd. | 19 | 2026-03-31 |
| Ray Co., Ltd. | 15 | 2026-04-09 |
| Prexion Corporation | 9 | 2023-09-08 |
| Palodex Group OY | 8 | 2024-09-12 |
| Cefla S.C. | 7 | 2026-03-10 |
39 more applicants have OAS clearances. See the full list in Caduvo.
Most recent OAS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260462 | Ray Co., Ltd. | RCT800 | 2026-04-09 | 56 |
| K260093 | VATECH Co., Ltd. | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | 2026-03-31 | 77 |
| K252353 | Cefla S.C. | myray ProXIma X6 | 2026-03-10 | 224 |
| K253959 | Dentsply Sirona | Primevision 3D | 2026-02-05 | 57 |
| K251798 | Ray Co., Ltd. | RCT700 | 2025-11-25 | 166 |
Recalls for OAS devices
7 product recalls in 5 recall events; 4 initiated in the last five years and 6 still open. Most recent: 2025-08-26.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 2 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code OAS?
OAS is the FDA product code for x-ray, tomography, computed, dental. It is a Class II device, regulated under 21 CFR 892.1750 and reviewed by the Radiology panel.
What device class is OAS?
Class II, regulation 21 CFR 892.1750. Typical premarket route: 510(k).
How long does a 510(k) take for product code OAS?
Across 131 cleared submissions the average was 137 days from receipt to decision (median 113).
Which companies have the most OAS clearances?
VATECH Co., Ltd. (19); Ray Co., Ltd. (15); Prexion Corporation (9); Palodex Group OY (8); Cefla S.C. (7).
Have OAS devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2025-08-26.
Next steps
- Run an FDA pathway report with predicate devices for product code OAS
- Run a recall and safety report across every OAS manufacturer
- Watch product code OAS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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