FDA product code · Radiology · Class 2
OEB: Lung Computed Tomography System, Computer-Aided Detection
OEB is FDA's product code for "Lung Computed Tomography System, Computer-Aided Detection": a Class 2 device classified under 21 CFR 892.2050, reviewed by the Radiology panel.
510(k) review time for OEB
Across 11 510(k) clearances under OEB decided from 2018-01-01 to 2026-10-06, the median was 185 days from FDA receipt to decision. Half took between 153 and 265 days, and 80% were decided within 267 days. These are past clearances, not a forecast for a new submission.
| Fastest | 86 |
|---|---|
| 25th percentile | 153 |
| Median | 185 |
| 75th percentile | 265 |
| 80th percentile | 267 |
| 90th percentile | 267 |
| Slowest | 443 |
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.
FDA-recognized standards that cite OEB
No FDA recognized consensus standard cites OEB by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.