IZP
10 FDA 510(k) clearances · Product code
58 daysmedian time to decision
169 days90th percentile
10clearances measured
FDA profile
- Official device name
- Programmer, Changer, Film/Cassette, Radiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1870
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1993: 1 · 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MPQ-42 (K934944) | Elema-Schonander, Inc. | 1993-12-15 |
| PHILIPS ANGIOPRO (K911888) | Philips Medical Systems North America, Inc. | 1991-10-15 |
| PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM (K904144) | Mallinckrodt Group, Inc. | 1990-12-13 |
| SEP 90 (K904103) | Elema-Schonander, Inc. | 1990-11-20 |
| OMNIPLANE 200 FILM CHANGER SYSTEM (K874451) | Medrad, Inc. | 1988-02-11 |
| THE CSE FILM CHANGER SYSTEM (K854251) | Changer Service & Engineering, Inc. | 1985-10-28 |
| SEP PROGRAMMER FOR PUCK U & UD FILMCHANG (K842903) | Elema-Schonander, Inc. | 1984-08-21 |
| MAXIMAX - 4 (K841649) | Cgr Medical Corp. | 1984-06-05 |
| LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM (K841732) | Sybron Corp. | 1984-06-05 |
| SEP PROGRAMMER SEP-M/SINGLE-PLANE & (K840389) | Elema-Schonander, Inc. | 1984-02-21 |
Track IZP automatically
Every clearance here is in the API, with alerts when new ones post.