FDA product code IZP: Programmer, Changer, Film/Cassette, Radiographic
IZP is the FDA product code for programmer, changer, film/cassette, radiographic. It is a Class II device, regulated under 21 CFR 892.1870 and reviewed by the Radiology panel. FDA has cleared 10 510(k) submissions under IZP, from 7 different applicants. The average 510(k) review took 65 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Programmer, Changer, Film/Cassette, Radiographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1870 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every IZP clearance
Top IZP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elema-Schonander, Inc. | 4 | 1993-12-15 |
| Philips Medical Systems North America, Inc. | 1 | 1991-10-15 |
| Mallinckrodt Group, Inc. | 1 | 1990-12-13 |
| Medrad, Inc. | 1 | 1988-02-11 |
| Changer Service & Engineering, Inc. | 1 | 1985-10-28 |
2 more applicants have IZP clearances. See the full list in Caduvo.
Most recent IZP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934944 | Elema-Schonander, Inc. | MPQ-42 | 1993-12-15 | 58 |
| K911888 | Philips Medical Systems North America, Inc. | PHILIPS ANGIOPRO | 1991-10-15 | 169 |
| K904144 | Mallinckrodt Group, Inc. | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM | 1990-12-13 | 97 |
| K904103 | Elema-Schonander, Inc. | SEP 90 | 1990-11-20 | 75 |
| K874451 | Medrad, Inc. | OMNIPLANE 200 FILM CHANGER SYSTEM | 1988-02-11 | 106 |
Recalls for IZP devices
openFDA lists no recalls for product code IZP.
Frequently asked questions
What is FDA product code IZP?
IZP is the FDA product code for programmer, changer, film/cassette, radiographic. It is a Class II device, regulated under 21 CFR 892.1870 and reviewed by the Radiology panel.
What device class is IZP?
Class II, regulation 21 CFR 892.1870. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code IZP?
Across 10 cleared submissions the average was 65 days from receipt to decision (median 52).
Which companies have the most IZP clearances?
Elema-Schonander, Inc. (4); Philips Medical Systems North America, Inc. (1); Mallinckrodt Group, Inc. (1); Medrad, Inc. (1); Changer Service & Engineering, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IZP
- Run a recall and safety report across every IZP manufacturer
- Watch product code IZP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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