Product code IXA— Radiology

FDA has cleared 51 devices under product code IXA between 1977 and 2008, filed by 31 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20081 clearance
• 20051 clearance
• 20041 clearance
• 20022 clearances
• 20013 clearances
• 19991 clearance
• 19981 clearance
• 19973 clearances
• 19962 clearances
• 19957 clearances
• 19945 clearances
• 19936 clearances
• 19921 clearance
• 19911 clearance
• 19904 clearances

• Eastman Kodak Company13 clearances
• E.I. Dupont DE Nemours & Co., Inc.6 clearances
• Mci Optonix, Inc.2 clearances
• Fujifilm Medical System U.S.A., Inc.2 clearances
• Dupont Medical Products2 clearances
• X-Ray Accessories Mfg. Co.1 clearance
• Victoreen, Inc.1 clearance
• Unidex Group, Inc.1 clearance
• Umi Intl.1 clearance
• The DU Pont Co.1 clearance

• K081557 — PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDERJddb Manufacturing, Inc.·2008-09-10
• K053173 — DS CASSETTEKonica Minolta Medical & Graphic, Inc.·2005-12-15
• K040378 — KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253Eastman Kodak Company·2004-05-24
• K023020 — AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTEAgfa Corp.·2002-09-26
• K021903 — KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USEEastman Kodak Company·2002-07-10
• K013686 — KODAK DIRECTVIEW TABLETOP CASSETTEEastman Kodak Company·2001-12-07
• K013229 — LIFERAY FW MAMMO CASSETTE, LIFERAY KW MAMMO CASETTEFerrania USA, Inc.·2001-10-12
• K012373 — LIFERAY WL CASSETTE, LIFERAY KW CASSETTEFerrania S.P.A.·2001-08-09
• K983918 — RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)Mastek, Inc.·1999-03-12
• K980722 — TRIMAX RADIOGRAPHIC CASSETTEImation Corp.·1998-03-23
• K963914 — CM & CM DS-7Konica Medical Corp.·1997-10-08
• K971431 — UMI X-RAY FILM CASSETTEUmi Intl.·1997-05-20
• K970090 — SOLO-SLEDSolo-Sled, LLC·1997-04-21
• K961453 — KODAK MN-R 2000 CASSETTEEastman Kodak Company·1996-07-25
• K962336 — RADIOGRAPHIC FILM CASSETTESUnidex Group, Inc.·1996-07-03
• K953724 — CRONEX RADIATION THERAPY CASSETTEE.I. Dupont DE Nemours & Co., Inc.·1995-09-06
• K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTEE.I. Dupont DE Nemours & Co., Inc.·1995-09-06
• K953444 — MCI OPTONIX ECONOMY CASSETTEMci Optonix, Inc.·1995-08-02
• K952891 — CRONEX LOW ABSORPTION CASSETTEThe DU Pont Co.·1995-07-13
• K951006 — KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)Kenex , Ltd.·1995-04-03
• K945858 — X-RAY FILM CASSETTEJ.P.I. Chicago Co.·1995-03-21
• K945328 — JPI X-RAY FILM CASSETTEJpi America, Inc.·1995-01-20
• K945039 — MCI OPTONIX CASSETTE OKAMOTO CASSETEMci Optonix, Inc.·1994-11-22
• K941600 — MT-300 CASSETTE HOLDERMedtec, Inc.·1994-09-16
• K942481 — FUJI ULTIMA EC-MA CASSETTEFujifilm Medical System U.S.A., Inc.·1994-07-29
• K941475 — CRONEX REGULAR CASSETTEDupont Medical Products·1994-07-20
• K941518 — DUPONT CRONEX PORTABLE GRID CASSETTEDupont Medical Products·1994-06-06
• K935397 — NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERSVictoreen, Inc.·1993-12-15
• K932565 — FUJIFILM EC-B SERIES CASETTEFujifilm Medical System U.S.A., Inc.·1993-07-26
• K931074 — DU PONT MV DARKROOM CASSETTEE.I. Dupont DE Nemours & Co., Inc.·1993-06-08
• K930220 — CASSETTE, RADIOGRAPHIC FILMX-Ray Accessories Mfg. Co.·1993-04-13
• K930244 — JPI X-RAY FILM CASSETTEJpi, Inc.·1993-04-07
• K923334 — MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDERCook, Inc.·1993-01-26
• K921826 — KODAK INSIGHT PORTABLE IMAGING SYSTEMEastman Kodak Company·1992-08-26
• K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPEInvotec International, Inc.·1991-06-04
• K896708 — PERLINK CASSETTE, KIRAN CASSETTEPerlink USA, Inc.·1990-05-07
• K901013 — RADIOGRAPHIC FILM CASSETTEInfab Corp.·1990-03-28
• K900620 — DU PONT MAMMOGRAPHY CASSETTEE.I. Dupont DE Nemours & Co., Inc.·1990-02-26
• K895335 — CRONEX COMPACT MAMMOGRAPHY CASSETTEE.I. Dupont DE Nemours & Co., Inc.·1990-02-16
• K893728 — PINK CASSETTE CADDIEMedical Technique Instruments, Inc.·1989-09-18
• K890750 — KODAK X-OMATIC RA CASSETTEEastman Kodak Company·1989-03-01
• K890361 — KODAK MIN-R 2 CASSETTEEastman Kodak Company·1989-02-24
• K885178 — KODAFLEX II RADIATION THERAPY L CASSETTEEastman Kodak Company·1989-02-03
• K883312 — L-F/KODAK FLEXIBLE GRID CASSETTEMallinckrodt Group, Inc.·1988-08-16
• K875083 — KODAK KODAFLEX II CASSETTEEastman Kodak Company·1988-01-19
• K860754 — KODAK T-MAT M FILM SO-245Eastman Kodak Company·1986-03-06
• K850415 — CRONEX KEVLAR CASSETTEE.I. Dupont DE Nemours & Co., Inc.·1985-05-14
• K843176 — KODAK X-OMATIC RADIATION THERAPY CASSEastman Kodak Company·1984-08-27
• K812535 — PLASTILIX MINIRAD D CASSETTEEastman Kodak Company·1981-10-19
• K792721 — HUESTIS FLEXI-HOLDERHuestis Machine Corp.·1980-02-19
• K771682 — MIN-R CASSETTEEastman Kodak Company·1977-09-20