Atlas FDA

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

JWM — Predicate Candidate Screening

17 FDA 510(k) clearances under this product code; the 50 most recent screened below.

52 daysmedian FDA review time
195 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K914350ICON COMPUTER SYSTEMSiemens Gammasonics, Inc.1991-11-22561
K904599D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEMDigital Design, Inc.1991-04-231950
K903315ICONSiemens Gammasonics, Inc.1991-01-091691
K901545GCA-9300 NUCLEAR TOMOGRAPHY SYSTEMToshiba America Medical Systems, In.C1990-06-26840
K874473ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEMAdac Laboratories1988-07-182590
K873075ADAC MODEL ARC-5000, GAMMA CAMERAAdac Laboratories1987-10-30850
K851685DIGITAL GAMMA CAMERA GCA 601 EToshiba Medical Systems1985-06-14520
K850885STARCAM DATA ACQUISITION & PROCESSING SYS H3300CGeneral Electric Co.1985-06-06940
K851687JUMBO DIGITAL GAMMACAMERA GCA-90BToshiba Medical Systems1985-06-05430
K851686DIGITAL GAMMA CAMERA GCA 501SToshiba Medical Systems1985-06-05430
K841905DOT-A, DOT-AR PXP-E, PXP-ERSiemens Gammasonics, Inc.1984-08-09940
K832737ECT PROCESSORSiemens Gammasonics, Inc.1983-09-29490
K812966400T ECT SOFTWAREGeneral Electric Co.1981-11-24330
K810873STARIntl. General Electric Co.1981-04-23230
K801917STARGeneral Electric Co.1980-09-16360
K780368MODUMED MUGXMedtronic Vascular1978-03-1470
K780369MODUMED MUGEMedtronic Vascular1978-03-1470

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