Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Quantum Medical Imaging, LLC · Predicate Candidate Screening

5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

36 daysmedian FDA review time
106 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K083181QV-9000 UNIVERSAL SYSTEMQuantum Medical Imaging, LLC2008-11-26290
K080905QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDIQuantum Medical Imaging, LLC2008-07-161060
K072010QUANTUM DIREX SYSTEMQuantum Medical Imaging, LLC2007-08-07150
K023008UNIVERSAL SYSTEM, MODEL QV-800Quantum Medical Imaging, LLC2002-11-13650
K011486Q-RAD RADIOGRAPHIC SYSTEMQuantum Medical Imaging, LLC2001-06-20360

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda