Atlas FDA

KPX

26 FDA 510(k) clearances · Product code

41 daysmedian time to decision
144 days90th percentile
26clearances measured

FDA profile

Official device name
Changer, Radiographic Film/Cassette
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1860
Medical specialty
Radiology
Adverse events (MAUDE)
1993: 3 · 1996: 1 · 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
TRANS X-1000 (K945635)Canon USA, Inc.1995-02-01
ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES (K935157)Regulatory Consultants TO the Medical Device Indus1994-08-09
NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS (K934850)Victoreen, Inc.1993-11-22
BCM-600TX (K933035)B C Medical , Ltd.1993-10-08
BUCKYMATIC AUTOMATIC CHEST FILM CHANGER (K925598)Acoma Medical Imaging, Inc.1993-02-01
MWX-7440 HIGH SPEED BUCKY (K924423)Midwest X-Ray Equipment Co.1993-01-15
SHIMADZU RADIOGRAPJHIC STAND BR-100 (K925169)Shimadzu Medical Systems1992-12-03
OX-600 (K920196)Stardard X-Ray Sales Co.1992-10-14
DU PONT COMPACT DAYLIGHT SYSTEM 2000 (K922483)E.I. Dupont DE Nemours & Co., Inc.1992-09-11
FRANKLIN 9000 WALL STAND (K905789)Mallinckrodt Group, Inc.1991-05-20
AUTOMATIC CASSETTE LOADER (K902761)Mallinckrodt Group, Inc.1990-10-09
PUCK 90M (K903576)Elema-Schonander, Inc.1990-09-04
ADDITIONAL MODEL TO CANON UNIVERSAL STAND (K870048)Canon USA, Inc.1987-01-12
UNIVERSAL STAND FOR FILM CHANGER (K862575)Canon USA, Inc.1986-07-14
UNIVERSAL STAND FOR FILM CHANGER (K853928)Canon USA, Inc.1985-10-28
CANON X-RAY FILM CHANGER CFC-U1 (K851067)Canon USA, Inc.1985-05-21
PUCK U & UD CUTFILM CHANGERS (K842911)Elema-Schonander, Inc.1984-08-21
AUTOMATIC TRAY (ACT I & ACT II (K820117)Burbury & Cutter Ind., Inc.1982-02-18
CP-625 SEE-THRU FILM CHANGER (K811967)Philips Medical Systems (Cleveland), Inc.1981-08-13
XEROX 128 CASSETTE CHANGER (K812024)Xerox Medical Systems1981-08-13
BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO (K801950)B C Medical , Ltd.1980-10-03
RADX VENT-AL MECHANICAL RESPORATOR (K800751)Radx Corp.1980-05-08
MEMCO 300 FILM CHANGER (K792068)Memco, Inc.1979-11-16
SPECTRUM AUTOMATIC CHEST UNIT MODEL C (K791811)Spectrum X-Ray Corp.1979-10-26
ULTIMAT L4 X L4, LIEBEL-FLARSHEIM (K770836)Mallinckrodt Group, Inc.1977-05-26
X-RAY FILM, CONVEY OR SYSTEM (K760279)Mallinckrodt Group, Inc.1976-08-13

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