IZP · Programmer, Changer, Film/Cassette, Radiographic
Radiology · 21 CFR 892.1870 · Class 2
Overview
| Product Code | IZP |
|---|---|
| Device Name | Programmer, Changer, Film/Cassette, Radiographic |
| Regulation | 21 CFR 892.1870 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A radiographic film/cassette changer programmer is a device intended to be used to control the operations of a film or cassette changer during serial medical radiography.
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 (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934944 | MPQ-42 | Elema-Schonander, Inc. | Dec 15, 1993 | SESE |
| K911888 | PHILIPS ANGIOPRO | Philips Medical Systems North America, Inc. | Oct 15, 1991 | SESE |
| K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | Mallinckrodt Group, Inc. | Dec 13, 1990 | SESE |
| K904103 | SEP 90 | Elema-Schonander, Inc. | Nov 20, 1990 | SESE |
| K874451 | OMNIPLANE 200 FILM CHANGER SYSTEM | Medrad, Inc. | Feb 11, 1988 | SESE |
| K854251 | THE CSE FILM CHANGER SYSTEM | Changer Service & Engineering, Inc. | Oct 28, 1985 | SESE |
| K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Elema-Schonander, Inc. | Aug 21, 1984 | SESE |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Sybron Corp. | Jun 5, 1984 | SESE |
| K841649 | MAXIMAX - 4 | Cgr Medical Corp. | Jun 5, 1984 | SESE |
| K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & | Elema-Schonander, Inc. | Feb 21, 1984 | SESE |
Top Applicants
- Elema-Schonander, Inc. — 4 clearances
- Sybron Corp. — 1 clearance
- Philips Medical Systems North America, Inc. — 1 clearance
- Medrad, Inc. — 1 clearance
- Mallinckrodt Group, Inc. — 1 clearance
