Product code KPX
- Device name
- Changer, Radiographic Film/Cassette
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1860
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945635 | TRANS X-1000 | Canon USA, Inc. | 1995-02-01 |
| K935157 | ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES | Regulatory Consultants TO the Medical Device Indus | 1994-08-09 |
| K934850 | NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS | Victoreen, Inc. | 1993-11-22 |
| K933035 | BCM-600TX | B C Medical , Ltd. | 1993-10-08 |
| K925598 | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | Acoma Medical Imaging, Inc. | 1993-02-01 |
| K924423 | MWX-7440 HIGH SPEED BUCKY | Midwest X-Ray Equipment Co. | 1993-01-15 |
| K925169 | SHIMADZU RADIOGRAPJHIC STAND BR-100 | Shimadzu Medical Systems | 1992-12-03 |
| K920196 | OX-600 | Stardard X-Ray Sales Co. | 1992-10-14 |
| K922483 | DU PONT COMPACT DAYLIGHT SYSTEM 2000 | E.I. Dupont DE Nemours & Co., Inc. | 1992-09-11 |
| K905789 | FRANKLIN 9000 WALL STAND | Mallinckrodt Group, Inc. | 1991-05-20 |
| K902761 | AUTOMATIC CASSETTE LOADER | Mallinckrodt Group, Inc. | 1990-10-09 |
| K903576 | PUCK 90M | Elema-Schonander, Inc. | 1990-09-04 |
| K870048 | ADDITIONAL MODEL TO CANON UNIVERSAL STAND | Canon USA, Inc. | 1987-01-12 |
| K862575 | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | 1986-07-14 |
| K853928 | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | 1985-10-28 |
| K851067 | CANON X-RAY FILM CHANGER CFC-U1 | Canon USA, Inc. | 1985-05-21 |
| K842911 | PUCK U & UD CUTFILM CHANGERS | Elema-Schonander, Inc. | 1984-08-21 |
| K820117 | AUTOMATIC TRAY (ACT I & ACT II | Burbury & Cutter Ind., Inc. | 1982-02-18 |
| K812024 | XEROX 128 CASSETTE CHANGER | Xerox Medical Systems | 1981-08-13 |
| K811967 | CP-625 SEE-THRU FILM CHANGER | Philips Medical Systems (Cleveland), Inc. | 1981-08-13 |
| K801950 | BCM-600 MINI-SIX EXTRA LG. FIELD ANGIO | B C Medical , Ltd. | 1980-10-03 |
| K800751 | RADX VENT-AL MECHANICAL RESPORATOR | Radx Corp. | 1980-05-08 |
| K792068 | MEMCO 300 FILM CHANGER | Memco, Inc. | 1979-11-16 |
| K791811 | SPECTRUM AUTOMATIC CHEST UNIT MODEL C | Spectrum X-Ray Corp. | 1979-10-26 |
| K770836 | ULTIMAT L4 X L4, LIEBEL-FLARSHEIM | Mallinckrodt Group, Inc. | 1977-05-26 |
| K760279 | X-RAY FILM, CONVEY OR SYSTEM | Mallinckrodt Group, Inc. | 1976-08-13 |