KPX · Changer, Radiographic Film/Cassette
Radiology · 21 CFR 892.1860 · Class 2
Overview
| Product Code | KPX |
|---|---|
| Device Name | Changer, Radiographic Film/Cassette |
| Regulation | 21 CFR 892.1860 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A radiographic film/cassette changer is a device intended to be used during a radiologic procedure to move a radiographic film or cassette between x-ray exposures and to position it during the exposure.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945635 | TRANS X-1000 | Canon USA, Inc. | Feb 1, 1995 | SESE |
| K935157 | ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES | Regulatory Consultants TO the Medical Device Indus | Aug 9, 1994 | SESE |
| K934850 | NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS | Victoreen, Inc. | Nov 22, 1993 | SESE |
| K933035 | BCM-600TX | B C Medical , Ltd. | Oct 8, 1993 | SESE |
| K925598 | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER | Acoma Medical Imaging, Inc. | Feb 1, 1993 | SESE |
| K924423 | MWX-7440 HIGH SPEED BUCKY | Midwest X-Ray Equipment Co. | Jan 15, 1993 | SESE |
| K925169 | SHIMADZU RADIOGRAPJHIC STAND BR-100 | Shimadzu Medical Systems | Dec 3, 1992 | SESE |
| K920196 | OX-600 | Stardard X-Ray Sales Co. | Oct 14, 1992 | SESE |
| K922483 | DU PONT COMPACT DAYLIGHT SYSTEM 2000 | E.I. Dupont DE Nemours & Co., Inc. | Sep 11, 1992 | SESE |
| K905789 | FRANKLIN 9000 WALL STAND | Mallinckrodt Group, Inc. | May 20, 1991 | SESE |
| K902761 | AUTOMATIC CASSETTE LOADER | Mallinckrodt Group, Inc. | Oct 9, 1990 | SESE |
| K903576 | PUCK 90M | Elema-Schonander, Inc. | Sep 4, 1990 | SESE |
| K870048 | ADDITIONAL MODEL TO CANON UNIVERSAL STAND | Canon USA, Inc. | Jan 12, 1987 | SESE |
| K862575 | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | Jul 14, 1986 | SESE |
| K853928 | UNIVERSAL STAND FOR FILM CHANGER | Canon USA, Inc. | Oct 28, 1985 | SESE |
| K851067 | CANON X-RAY FILM CHANGER CFC-U1 | Canon USA, Inc. | May 21, 1985 | SESE |
| K842911 | PUCK U & UD CUTFILM CHANGERS | Elema-Schonander, Inc. | Aug 21, 1984 | SESE |
| K820117 | AUTOMATIC TRAY (ACT I & ACT II | Burbury & Cutter Ind., Inc. | Feb 18, 1982 | SESE |
| K812024 | XEROX 128 CASSETTE CHANGER | Xerox Medical Systems | Aug 13, 1981 | SESE |
| K811967 | CP-625 SEE-THRU FILM CHANGER | Philips Medical Systems (Cleveland), Inc. | Aug 13, 1981 | SESE |
Top Applicants
- Canon USA, Inc. — 5 clearances
- Mallinckrodt Group, Inc. — 4 clearances
- Elema-Schonander, Inc. — 2 clearances
- B C Medical , Ltd. — 2 clearances
- Xerox Medical Systems — 1 clearance
