Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1870](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1870) → IZP — Programmer, Changer, Film/Cassette, Radiographic

# IZP · Programmer, Changer, Film/Cassette, Radiographic

_Radiology · 21 CFR 892.1870 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP

## Overview

- **Product Code:** IZP
- **Device Name:** Programmer, Changer, Film/Cassette, Radiographic
- **Regulation:** [21 CFR 892.1870](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1870)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K934944.md) | MPQ-42 | Elema-Schonander, Inc. | Dec 15, 1993 | SESE |
| [K911888](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K911888.md) | PHILIPS ANGIOPRO | Philips Medical Systems North America, Inc. | Oct 15, 1991 | SESE |
| [K904144](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K904144.md) | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | Mallinckrodt Group, Inc. | Dec 13, 1990 | SESE |
| [K904103](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K904103.md) | SEP 90 | Elema-Schonander, Inc. | Nov 20, 1990 | SESE |
| [K874451](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K874451.md) | OMNIPLANE 200 FILM CHANGER SYSTEM | Medrad, Inc. | Feb 11, 1988 | SESE |
| [K854251](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K854251.md) | THE CSE FILM CHANGER SYSTEM | Changer Service & Engineering, Inc. | Oct 28, 1985 | SESE |
| [K842903](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K842903.md) | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG | Elema-Schonander, Inc. | Aug 21, 1984 | SESE |
| [K841732](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K841732.md) | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Sybron Corp. | Jun 5, 1984 | SESE |
| [K841649](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K841649.md) | MAXIMAX - 4 | Cgr Medical Corp. | Jun 5, 1984 | SESE |
| [K840389](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP/K840389.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZP)

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