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

EAM — Predicate Candidate Screening

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

46 daysmedian FDA review time

150 days90th percentile

35clearances measured

K-number	Device	Applicant	Decided	Review days
K974423	ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FA	Sterling Diagnostic Imaging, Inc.	1997-12-22	28
K963913	MD100 & MM150	Konica Medical Corp.	1997-10-08	373
K954161	JPI INTENSIFYING SCREEN	Jpi Healthcare Co, Ltd.	1996-02-02	150
K943821	KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC	Fujifilm Medical System U.S.A., Inc.	1994-08-22	68
K943822	FUJI UM MAMMO SERIES INTENSIFY SCREENS:	Fujifilm Medical System U.S.A., Inc.	1994-08-22	68
K943823	FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12	Fujifilm Medical System U.S.A., Inc.	1994-08-22	68
K942235	KYOKKO GREEN SERIES INTENSIFYING SCREENS	Fujifilm Medical System U.S.A., Inc.	1994-08-17	100
K943425	FUJI HG-M INTENSIFYING SCREEN	Fujifilm Medical System U.S.A., Inc.	1994-08-17	33
K942805	KYOKKO BLUE SERIES INTENSIFYING SCREENS	Fujifilm Medical System U.S.A., Inc.	1994-07-29	44
K942909	KODAK INSIGHT TWIN-LOAD INSERT	Eastman Kodak Company	1994-07-29	38
K942399	KYOKKO UM SERIES INTENSIFYING SCREEN	Fujifilm Medical System U.S.A., Inc.	1994-06-10	22
K941023	RAREX GREEN FAST	Mci Optonix, Inc.	1994-03-30	27
K933161	ULTRA-VISION SUPER RAPID INTENSIFYING SCREEN	Dupont Medical Products	1993-10-07	100
K931283	MICROVISION FAST DETAIL INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1993-06-08	88
K920190	ULTRA-VISION RAPID INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1992-05-28	134
K920200	ULTRA-VISION DETAIL INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1992-05-28	134
K920194	ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1992-05-27	133
K896707	PERLINK SCREEN, KIRAN SCREEN	Perlink USA, Inc.	1990-08-30	275
K902039	RAREX & OPTEX X-RAY SCREENS	Mci Optonix, Inc.	1990-07-27	84
K901014	RADIOGRAPHIC INTENSIFYING SCREEN	Infab Corp.	1990-04-02	28
K900448	CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1990-02-16	24
K900103	CRONEX QUANTA SR300 INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1990-02-05	27
K900318	CRONEX QUANTA SUPER RAPID SR339 RARE EARTH	E.I. Dupont DE Nemours & Co., Inc.	1990-02-05	13
K893510	CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN	E.I. Dupont DE Nemours & Co., Inc.	1989-06-23	49
K873167	KODAK MIN-R MEDIUM SCREEN	Eastman Kodak Company	1987-08-27	16
K862414	FUJI CR IMAGING PLATE	Parexel Intl. Corp.	1987-02-26	246
K860755	KODAK MIN-R FAST SCREEN SO-459	Eastman Kodak Company	1986-03-06	6
K845030	CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS	E.I. Dupont DE Nemours & Co., Inc.	1985-02-26	61
K834484	CRONEX SR-337	E.I. Dupont DE Nemours & Co., Inc.	1984-02-21	82
K813147	KODAK INTENSIFYING SCREEN 80-175	Eastman Kodak Company	1981-12-14	38
K813139	KODAK INTENSIFYING SCREEN SO-168	Eastman Kodak Company	1981-12-08	32
K792123	KODAK LANEX MED. SCREEN	Eastman Kodak Company	1979-12-10	46
K770837	SCREEN, FINE, LANES, KODAK	Eastman Kodak Company	1977-05-26	20
K770574	CRONEX QUANTA III INTENSIFYING SCREENS	E.I. Dupont DE Nemours & Co., Inc.	1977-04-05	8
K770094	FLUORICON 500 IMAGE INTENSIFIERS	General Electric Co.	1977-01-21	4

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