KPXClass II
Changer, Radiographic Film/cassette
Radiology · 21 CFR 892.1860
MDR events6All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances26All time
Recent MDR events
6 adverse event reports on file
- AMBER-CUMay 30, 1997MalfunctionOldelft B.v.1180516-1997-00002
- AMBER-AUMay 30, 1997MalfunctionOldelft B.v.1180516-1997-00001
- PUCK FILM CHANGERMay 2, 1996MalfunctionSiemens Medical Systems, Inc.MW1009011
- PUCK FILM CHANGEDec 14, 1993Siemens Medical SystemsMW1000183
- PUCKDec 7, 1993InjurySiemens Medical Systems7287
- SCHONANDER-ELEMA AB FILM CHANGERAug 18, 1993Siemens Medical SystemsMW4000025
Event type breakdown
Malfunction3
Unspecified2
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
26 clearances for this product code
- Canon USA, Inc.Feb 1, 1995
K945635 · TRANS X-1000
- Regulatory Consultants TO the Medical Device IndusAug 9, 1994
K935157 · ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES
- Victoreen, Inc.Nov 22, 1993
K934850 · NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS
- B C Medical , Ltd.Oct 8, 1993
K933035 · BCM-600TX
- Acoma Medical Imaging, Inc.Feb 1, 1993
K925598 · BUCKYMATIC AUTOMATIC CHEST FILM CHANGER
- Midwest X-Ray Equipment Co.Jan 15, 1993
K924423 · MWX-7440 HIGH SPEED BUCKY
- Shimadzu Medical SystemsDec 3, 1992
K925169 · SHIMADZU RADIOGRAPJHIC STAND BR-100
- Stardard X-Ray Sales Co.Oct 14, 1992
K920196 · OX-600