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FDA product code · Radiology · Class 2

QBS: Radiological Computer Assisted Detection/Diagnosis Software For Fracture

QBS is FDA's product code for "Radiological Computer Assisted Detection/Diagnosis Software For Fracture": a Class 2 device classified under 21 CFR 892.2090, reviewed by the Radiology panel.

510(k) review time for QBS

Across 10 510(k) clearances under QBS decided from 2018-01-01 to 2026-10-06, the median was 181 days from FDA receipt to decision. Half took between 126 and 221 days, and 80% were decided within 225 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QBS, decisions 2018-01-01 to 2026-10-06 (n = 10)
Fastest96
25th percentile126
Median181
75th percentile221
80th percentile225
90th percentile234
Slowest237

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 QBS

No FDA recognized consensus standard cites QBS 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.

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