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FDA product code · Radiology · Class 2

QDQ: Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer

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

510(k) review time for QDQ

Across 40 510(k) clearances under QDQ decided from 2018-01-01 to 2026-10-06, the median was 153 days from FDA receipt to decision. Half took between 112 and 194 days, and 80% were decided within 213 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, QDQ, decisions 2018-01-01 to 2026-10-06 (n = 40)
Fastest20
25th percentile112
Median153
75th percentile194
80th percentile213
90th percentile269
Slowest310
Median days by decision year, QDQ (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20211695
20241537
20252165
2026 (to 10-06, partial)15410

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.

QDQ in the public FDA record

Records naming QDQ, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years39

Counts of records, not of devices or events. Adverse event reports for QDQ 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 QDQ

No FDA recognized consensus standard cites QDQ 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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