Atlas FDA

IXA

51 FDA 510(k) clearances · Product code

47 daysmedian time to decision
132 days90th percentile
51clearances measured

FDA profile

Official device name
Cassette, Radiographic Film
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1850
Medical specialty
Radiology
Adverse events (MAUDE)
1994: 1 · 1996: 1 · 1998: 2 · 1999: 1 · 2001: 1 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER (K081557)Jddb Manufacturing, Inc.2008-09-10
DS CASSETTE (K053173)Konica Minolta Medical & Graphic, Inc.2005-12-15
KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 (K040378)Eastman Kodak Company2004-05-24
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE (K023020)Agfa Corp.2002-09-26
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE (K021903)Eastman Kodak Company2002-07-10
KODAK DIRECTVIEW TABLETOP CASSETTE (K013686)Eastman Kodak Company2001-12-07
LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTE (K013229)Ferrania USA, Inc.2001-10-12
LIFERAY WL CASSETTE, LIFERAY KW CASSETTE (K012373)Ferrania S.P.A.2001-08-09
RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP) (K983918)Mastek, Inc.1999-03-12
TRIMAX RADIOGRAPHIC CASSETTE (K980722)Imation Corp.1998-03-23
CM & CM DS-7 (K963914)Konica Medical Corp.1997-10-08
UMI X-RAY FILM CASSETTE (K971431)Umi Intl.1997-05-20
SOLO-SLED (K970090)Solo-Sled, LLC1997-04-21
KODAK MN-R 2000 CASSETTE (K961453)Eastman Kodak Company1996-07-25
RADIOGRAPHIC FILM CASSETTES (K962336)Unidex Group, Inc.1996-07-03
CRONEX RADIATION THERAPY CASSETTE (K953724)E.I. Dupont DE Nemours & Co., Inc.1995-09-06
CRONEX RADIATION THERAPY VERIFICATION CASSETTE (K953725)E.I. Dupont DE Nemours & Co., Inc.1995-09-06
MCI OPTONIX ECONOMY CASSETTE (K953444)Mci Optonix, Inc.1995-08-02
CRONEX LOW ABSORPTION CASSETTE (K952891)The DU Pont Co.1995-07-13
KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7) (K951006)Kenex , Ltd.1995-04-03
X-RAY FILM CASSETTE (K945858)J.P.I. Chicago Co.1995-03-21
JPI X-RAY FILM CASSETTE (K945328)Jpi America, Inc.1995-01-20
MCI OPTONIX CASSETTE OKAMOTO CASSETE (K945039)Mci Optonix, Inc.1994-11-22
MT-300 CASSETTE HOLDER (K941600)Medtec, Inc.1994-09-16
FUJI ULTIMA EC-MA CASSETTE (K942481)Fujifilm Medical System U.S.A., Inc.1994-07-29
CRONEX REGULAR CASSETTE (K941475)Dupont Medical Products1994-07-20
DUPONT CRONEX PORTABLE GRID CASSETTE (K941518)Dupont Medical Products1994-06-06
NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS (K935397)Victoreen, Inc.1993-12-15
FUJIFILM EC-B SERIES CASETTE (K932565)Fujifilm Medical System U.S.A., Inc.1993-07-26
DU PONT MV DARKROOM CASSETTE (K931074)E.I. Dupont DE Nemours & Co., Inc.1993-06-08
CASSETTE, RADIOGRAPHIC FILM (K930220)X-Ray Accessories Mfg. Co.1993-04-13
JPI X-RAY FILM CASSETTE (K930244)Jpi, Inc.1993-04-07
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER (K923334)Cook, Inc.1993-01-26
KODAK INSIGHT PORTABLE IMAGING SYSTEM (K921826)Eastman Kodak Company1992-08-26
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (K911041)Invotec International, Inc.1991-06-04
PERLINK CASSETTE, KIRAN CASSETTE (K896708)Perlink USA, Inc.1990-05-07
RADIOGRAPHIC FILM CASSETTE (K901013)Infab Corp.1990-03-28
DU PONT MAMMOGRAPHY CASSETTE (K900620)E.I. Dupont DE Nemours & Co., Inc.1990-02-26
CRONEX COMPACT MAMMOGRAPHY CASSETTE (K895335)E.I. Dupont DE Nemours & Co., Inc.1990-02-16
PINK CASSETTE CADDIE (K893728)Medical Technique Instruments, Inc.1989-09-18
KODAK X-OMATIC RA CASSETTE (K890750)Eastman Kodak Company1989-03-01
KODAK MIN-R 2 CASSETTE (K890361)Eastman Kodak Company1989-02-24
KODAFLEX II RADIATION THERAPY L CASSETTE (K885178)Eastman Kodak Company1989-02-03
L-F/KODAK FLEXIBLE GRID CASSETTE (K883312)Mallinckrodt Group, Inc.1988-08-16
KODAK KODAFLEX II CASSETTE (K875083)Eastman Kodak Company1988-01-19
KODAK T-MAT M FILM SO-245 (K860754)Eastman Kodak Company1986-03-06
CRONEX KEVLAR CASSETTE (K850415)E.I. Dupont DE Nemours & Co., Inc.1985-05-14
KODAK X-OMATIC RADIATION THERAPY CASS (K843176)Eastman Kodak Company1984-08-27
PLASTILIX MINIRAD D CASSETTE (K812535)Eastman Kodak Company1981-10-19
HUESTIS FLEXI-HOLDER (K792721)Huestis Machine Corp.1980-02-19
MIN-R CASSETTE (K771682)Eastman Kodak Company1977-09-20

Track IXA automatically

Every clearance here is in the API, with alerts when new ones post.