FDA product code · Radiology · Class 2
OAS: X-Ray, Tomography, Computed, Dental
OAS is FDA's product code for "X-Ray, Tomography, Computed, Dental": a Class 2 device classified under 21 CFR 892.1750, reviewed by the Radiology panel.
510(k) review time for OAS
Across 77 510(k) clearances under OAS decided from 2018-01-01 to 2026-10-06, the median was 92 days from FDA receipt to decision. Half took between 49 and 171 days, and 80% were decided within 198 days. These are past clearances, not a forecast for a new submission.
| Fastest | 14 |
|---|---|
| 25th percentile | 49 |
| Median | 92 |
| 75th percentile | 171 |
| 80th percentile | 198 |
| 90th percentile | 260 |
| Slowest | 448 |
| Year | Median days | n |
|---|---|---|
| 2018 | 57 | 11 |
| 2019 | 55 | 7 |
| 2020 | 113 | 9 |
| 2021 | 92 | 11 |
| 2022 | 105 | 6 |
| 2023 | 77 | 12 |
| 2025 | 144 | 9 |
| 2026 (to 10-06, partial) | 86 | 8 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
OAS in the public FDA record
| 510(k) clearances, all years | 135 |
|---|---|
| Establishment listings | 124 |
| GUDID device identifiers | 499 |
Counts of records, not of devices or events. Adverse event reports for OAS are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite OAS
2 FDA recognized consensus standards cite OAS, 1 of them recognized only in part, among them IEC 60601-2-44 Edition 3.2: 2016; IEC 61223-3-7 Edition 1.0 2021-12. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 12-302 IEC 60601-2-44 Edition 3.2: 2016 (partial recognition) — Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
- 12-345 IEC 61223-3-7 Edition 1.0 2021-12 — Evaluation and routine testing in medical imaging departments - Part 3-7: Acceptance and constancy tests - Imaging performance of X-ray equipment for dental cone beam computed tomography
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.