Atlas FDA

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

Cemax, Inc. — Predicate Candidate Screening

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

192 daysmedian FDA review time
282 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K950513ARCHIVEMANAGERCemax, Inc.1995-11-132800
K945188CEMAX VIPSTATION AND/OR SOFTWARECemax, Inc.1995-08-022820
K943357CEMAX SCANLINK VCemax, Inc.1994-11-221330
K932371CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARECemax, Inc.1994-02-182800
K932372CEMAX VIPSTATION(TM) AND/OR SOFTWARECemax, Inc.1993-11-221920
K905801CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIOCemax, Inc.1991-03-22840
K880169CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATIONCemax, Inc.1988-03-09540

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