Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Eastman Kodak Company · Predicate Candidate Screening

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

48 daysmedian FDA review time

127 days90th percentile

238clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K060550	KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS	Eastman Kodak Company	2006-03-31	29	2
K060137	KODAK ECLIPSE IMAGE PROCESSING SOFTWARE	Eastman Kodak Company	2006-03-16	56	0
K060079	KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM	Eastman Kodak Company	2006-02-08	29	0
K060055	KODAK PACS	Eastman Kodak Company	2006-02-07	29	0
K053347	KODAK CARESTREAM PACS	Eastman Kodak Company	2006-01-04	33	0
K051483	KODAK DIRECTVIEW DR SYSTEM DETECTOR	Eastman Kodak Company	2005-06-21	15	0
K051258	KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345	Eastman Kodak Company	2005-06-01	16	4
K042158	KODAK MEDICAL IMAGER 300	Eastman Kodak Company	2004-09-24	45	0
K042159	KODAK COLOR MEDICAL IMAGER 1000	Eastman Kodak Company	2004-09-24	45	0
K040378	KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253	Eastman Kodak Company	2004-05-24	97	0
K040556	TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY	Eastman Kodak Company	2004-04-07	36	0
K033821	KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY	Eastman Kodak Company	2004-02-20	73	0
K031132	CONSULTIVA CASE INPUT STATION, MODEL CIS-1	Eastman Kodak Company	2003-11-26	231	0
K030781	KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTV	Eastman Kodak Company	2003-05-29	79	0
K021903	KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE	Eastman Kodak Company	2002-07-10	30	0
K021829	MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM	Eastman Kodak Company	2002-07-02	28	0
K020635	KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRE	Eastman Kodak Company	2002-03-21	22	1
K013686	KODAK DIRECTVIEW TABLETOP CASSETTE	Eastman Kodak Company	2001-12-07	30	0
K012155	KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS	Eastman Kodak Company	2001-08-10	30	0
K002146	KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY	Eastman Kodak Company	2000-09-27	72	0
K983928	KODAK HOME HEALTH MONITORING SYSTEM	Eastman Kodak Company	2000-02-11	463	0
K983905	KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK	Eastman Kodak Company	1999-01-25	83	0
K973430	KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM	Eastman Kodak Company	1998-07-17	310	0
K981053	KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW	Eastman Kodak Company	1998-06-18	87	0
K980118	KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER	Eastman Kodak Company	1998-03-17	63	0
K974107	KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW)	Eastman Kodak Company	1998-01-21	82	0
K974086	KODAK DIGITAL SCIENCE CARDIAC VIEWER	Eastman Kodak Company	1998-01-20	83	0
K973476	KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER	Eastman Kodak Company	1997-11-10	56	0
K972847	KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D)	Eastman Kodak Company	1997-10-07	67	0
K972380	KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LI	Eastman Kodak Company	1997-09-11	77	0
K971973	KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER	Eastman Kodak Company	1997-08-25	88	0
K971894	KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM	Eastman Kodak Company	1997-08-20	90	0
K970154	KODAK EKTASIAN HG FILM (EHG-15)	Eastman Kodak Company	1997-04-04	78	0
K970059	KODAK MINILOADER(2000)	Eastman Kodak Company	1997-01-27	20	0
K962896	KODAK DIGITAL SCIENCE REMOTE CASSETTE	Eastman Kodak Company	1996-09-20	57	0
K961453	KODAK MN-R 2000 CASSETTE	Eastman Kodak Company	1996-07-25	100	0
K960834	KODAK EC-L CASSETTE	Eastman Kodak Company	1996-05-28	89	0
K960382	KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER	Eastman Kodak Company	1996-04-17	83	0
K954484	KODAK AUTOMIXER II PLUS	Eastman Kodak Company	1995-10-18	21	0
K951396	KODAK X-OMAT 3000 RA PROCESSOR	Eastman Kodak Company	1995-05-15	49	0
K951397	KODAK X-OMAT 5000 RA PROCESSOR	Eastman Kodak Company	1995-05-15	49	0
K942610	KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)	Eastman Kodak Company	1994-10-20	140	4
K940386	KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP	Eastman Kodak Company	1994-08-17	203	0
K942909	KODAK INSIGHT TWIN-LOAD INSERT	Eastman Kodak Company	1994-07-29	38	0
K941142	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN	Eastman Kodak Company	1994-06-13	95	3
K936116	KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS	Eastman Kodak Company	1994-04-29	127	0
K932728	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)	Eastman Kodak Company	1994-04-25	322	0
K934106	KODAK EKTACHEM DTSC II SLIDES (LI)	Eastman Kodak Company	1994-04-25	245	0
K934413	KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTR	Eastman Kodak Company	1994-04-25	227	1
K936138	KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION	Eastman Kodak Company	1994-04-08	106	0

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