Product code KPX— Radiology

FDA has cleared 26 devices under product code KPX between 1976 and 1995, filed by 17 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.

• 19951 clearance
• 19941 clearance
• 19934 clearances
• 19923 clearances
• 19911 clearance
• 19902 clearances
• 19871 clearance
• 19861 clearance
• 19852 clearances
• 19841 clearance
• 19821 clearance
• 19812 clearances
• 19802 clearances
• 19792 clearances
• 19771 clearance

• Canon USA, Inc.5 clearances
• Mallinckrodt Group, Inc.4 clearances
• Elema-Schonander, Inc.2 clearances
• B C Medical , Ltd.2 clearances
• Xerox Medical Systems1 clearance
• Victoreen, Inc.1 clearance
• Stardard X-Ray Sales Co.1 clearance
• Spectrum X-Ray Corp.1 clearance
• Shimadzu Medical Systems1 clearance
• Regulatory Consultants TO the Medical Device Indus1 clearance

• K945635 — TRANS X-1000Canon USA, Inc.·1995-02-01
• K935157 — ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBESRegulatory Consultants TO the Medical Device Indus·1994-08-09
• K934850 — NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDSVictoreen, Inc.·1993-11-22
• K933035 — BCM-600TXB C Medical , Ltd.·1993-10-08
• K925598 — BUCKYMATIC AUTOMATIC CHEST FILM CHANGERAcoma Medical Imaging, Inc.·1993-02-01
• K924423 — MWX-7440 HIGH SPEED BUCKYMidwest X-Ray Equipment Co.·1993-01-15
• K925169 — SHIMADZU RADIOGRAPJHIC STAND BR-100Shimadzu Medical Systems·1992-12-03
• K920196 — OX-600Stardard X-Ray Sales Co.·1992-10-14
• K922483 — DU PONT COMPACT DAYLIGHT SYSTEM 2000E.I. Dupont DE Nemours & Co., Inc.·1992-09-11
• K905789 — FRANKLIN 9000 WALL STANDMallinckrodt Group, Inc.·1991-05-20
• K902761 — AUTOMATIC CASSETTE LOADERMallinckrodt Group, Inc.·1990-10-09
• K903576 — PUCK 90MElema-Schonander, Inc.·1990-09-04
• K870048 — ADDITIONAL MODEL TO CANON UNIVERSAL STANDCanon USA, Inc.·1987-01-12
• K862575 — UNIVERSAL STAND FOR FILM CHANGERCanon USA, Inc.·1986-07-14
• K853928 — UNIVERSAL STAND FOR FILM CHANGERCanon USA, Inc.·1985-10-28
• K851067 — CANON X-RAY FILM CHANGER CFC-U1Canon USA, Inc.·1985-05-21
• K842911 — PUCK U & UD CUTFILM CHANGERSElema-Schonander, Inc.·1984-08-21
• K820117 — AUTOMATIC TRAY (ACT I & ACT IIBurbury & Cutter Ind., Inc.·1982-02-18
• K811967 — CP-625 SEE-THRU FILM CHANGERPhilips Medical Systems (Cleveland), Inc.·1981-08-13
• K812024 — XEROX 128 CASSETTE CHANGERXerox Medical Systems·1981-08-13
• K801950 — BCM-600 MINI-SIX EXTRA LG. FIELD ANGIOB C Medical , Ltd.·1980-10-03
• K800751 — RADX VENT-AL MECHANICAL RESPORATORRadx Corp.·1980-05-08
• K792068 — MEMCO 300 FILM CHANGERMemco, Inc.·1979-11-16
• K791811 — SPECTRUM AUTOMATIC CHEST UNIT MODEL CSpectrum X-Ray Corp.·1979-10-26
• K770836 — ULTIMAT L4 X L4, LIEBEL-FLARSHEIMMallinckrodt Group, Inc.·1977-05-26
• K760279 — X-RAY FILM, CONVEY OR SYSTEMMallinckrodt Group, Inc.·1976-08-13