Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXA — Predicate Candidate Screening
51 FDA 510(k) clearances under this product code; the 50 most recent screened below.
47 daysmedian FDA review time
132 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081557 | PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER | Jddb Manufacturing, Inc. | 2008-09-10 | 99 | 0 |
| K053173 | DS CASSETTE | Konica Minolta Medical & Graphic, Inc. | 2005-12-15 | 31 | 0 |
| K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 | Eastman Kodak Company | 2004-05-24 | 97 | 0 |
| K023020 | AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO C | Agfa Corp. | 2002-09-26 | 15 | 1 |
| K021903 | KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE | Eastman Kodak Company | 2002-07-10 | 30 | 0 |
| K013686 | KODAK DIRECTVIEW TABLETOP CASSETTE | Eastman Kodak Company | 2001-12-07 | 30 | 0 |
| K013229 | LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE | Ferrania USA, Inc. | 2001-10-12 | 15 | 0 |
| K012373 | LIFERAY WL CASSETTE, LIFERAY KW CASSETTE | Ferrania S.P.A. | 2001-08-09 | 14 | 0 |
| K983918 | RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) | Mastek, Inc. | 1999-03-12 | 128 | 0 |
| K980722 | TRIMAX RADIOGRAPHIC CASSETTE | Imation Corp. | 1998-03-23 | 27 | 0 |
| K963914 | CM & CM DS-7 | Konica Medical Corp. | 1997-10-08 | 373 | 0 |
| K971431 | UMI X-RAY FILM CASSETTE | Umi Intl. | 1997-05-20 | 33 | 0 |
| K970090 | SOLO-SLED | Solo-Sled, LLC | 1997-04-21 | 101 | 0 |
| K961453 | KODAK MN-R 2000 CASSETTE | Eastman Kodak Company | 1996-07-25 | 100 | 0 |
| K962336 | RADIOGRAPHIC FILM CASSETTES | Unidex Group, Inc. | 1996-07-03 | 16 | 0 |
| K953724 | CRONEX RADIATION THERAPY CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1995-09-06 | 27 | 0 |
| K953725 | CRONEX RADIATION THERAPY VERIFICATION CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1995-09-06 | 27 | 0 |
| K953444 | MCI OPTONIX ECONOMY CASSETTE | Mci Optonix, Inc. | 1995-08-02 | 16 | 0 |
| K952891 | CRONEX LOW ABSORPTION CASSETTE | The DU Pont Co. | 1995-07-13 | 20 | 0 |
| K951006 | KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) | Kenex , Ltd. | 1995-04-03 | 47 | 0 |
| K945858 | X-RAY FILM CASSETTE | J.P.I. Chicago Co. | 1995-03-21 | 110 | 0 |
| K945328 | JPI X-RAY FILM CASSETTE | Jpi America, Inc. | 1995-01-20 | 80 | 0 |
| K945039 | MCI OPTONIX CASSETTE OKAMOTO CASSETE | Mci Optonix, Inc. | 1994-11-22 | 39 | 0 |
| K941600 | MT-300 CASSETTE HOLDER | Medtec, Inc. | 1994-09-16 | 168 | 0 |
| K942481 | FUJI ULTIMA EC-MA CASSETTE | Fujifilm Medical System U.S.A., Inc. | 1994-07-29 | 65 | 0 |
| K941475 | CRONEX REGULAR CASSETTE | Dupont Medical Products | 1994-07-20 | 114 | 0 |
| K941518 | DUPONT CRONEX PORTABLE GRID CASSETTE | Dupont Medical Products | 1994-06-06 | 68 | 0 |
| K935397 | NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE | Victoreen, Inc. | 1993-12-15 | 36 | 0 |
| K932565 | FUJIFILM EC-B SERIES CASETTE | Fujifilm Medical System U.S.A., Inc. | 1993-07-26 | 60 | 0 |
| K931074 | DU PONT MV DARKROOM CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1993-06-08 | 98 | 0 |
| K930220 | CASSETTE, RADIOGRAPHIC FILM | X-Ray Accessories Mfg. Co. | 1993-04-13 | 88 | 0 |
| K930244 | JPI X-RAY FILM CASSETTE | Jpi, Inc. | 1993-04-07 | 78 | 0 |
| K923334 | MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER | Cook, Inc. | 1993-01-26 | 203 | 0 |
| K921826 | KODAK INSIGHT PORTABLE IMAGING SYSTEM | Eastman Kodak Company | 1992-08-26 | 132 | 0 |
| K911041 | INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE | Invotec International, Inc. | 1991-06-04 | 88 | 0 |
| K896708 | PERLINK CASSETTE, KIRAN CASSETTE | Perlink USA, Inc. | 1990-05-07 | 160 | 0 |
| K901013 | RADIOGRAPHIC FILM CASSETTE | Infab Corp. | 1990-03-28 | 23 | 0 |
| K900620 | DU PONT MAMMOGRAPHY CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-26 | 18 | 0 |
| K895335 | CRONEX COMPACT MAMMOGRAPHY CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1990-02-16 | 169 | 0 |
| K893728 | PINK CASSETTE CADDIE | Medical Technique Instruments, Inc. | 1989-09-18 | 124 | 0 |
| K890750 | KODAK X-OMATIC RA CASSETTE | Eastman Kodak Company | 1989-03-01 | 16 | 0 |
| K890361 | KODAK MIN-R 2 CASSETTE | Eastman Kodak Company | 1989-02-24 | 30 | 0 |
| K885178 | KODAFLEX II RADIATION THERAPY L CASSETTE | Eastman Kodak Company | 1989-02-03 | 51 | 0 |
| K883312 | L-F/KODAK FLEXIBLE GRID CASSETTE | Mallinckrodt Group, Inc. | 1988-08-16 | 11 | 0 |
| K875083 | KODAK KODAFLEX II CASSETTE | Eastman Kodak Company | 1988-01-19 | 41 | 0 |
| K860754 | KODAK T-MAT M FILM SO-245 | Eastman Kodak Company | 1986-03-06 | 6 | 0 |
| K850415 | CRONEX KEVLAR CASSETTE | E.I. Dupont DE Nemours & Co., Inc. | 1985-05-14 | 99 | 0 |
| K843176 | KODAK X-OMATIC RADIATION THERAPY CASS | Eastman Kodak Company | 1984-08-27 | 14 | 0 |
| K812535 | PLASTILIX MINIRAD D CASSETTE | Eastman Kodak Company | 1981-10-19 | 46 | 0 |
| K792721 | HUESTIS FLEXI-HOLDER | Huestis Machine Corp. | 1980-02-19 | 50 | 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