FDA product code IZG: System, X-Ray, Photofluorographic
IZG is the FDA product code for system, x-ray, photofluorographic. It is a Class II device, regulated under 21 CFR 892.1730 and reviewed by the Radiology panel. FDA has cleared 7 510(k) submissions under IZG, from 7 different applicants. The average 510(k) review took 180 days (median 155).
Classification
| Field | Value |
|---|---|
| Device name | System, X-Ray, Photofluorographic |
| Device class | Class II |
| Regulation | 21 CFR 892.1730 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every IZG clearance
Top IZG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spinal Specialties, Inc. | 1 | 1996-03-21 |
| GE Medical Systems | 1 | 1996-02-27 |
| Brotherston/Pxi | 1 | 1992-11-05 |
| Shimadzu Medical Systems | 1 | 1992-04-06 |
| B. Braun of America, Inc. | 1 | 1991-10-07 |
2 more applicants have IZG clearances. See the full list in Caduvo.
Most recent IZG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K960082 | Spinal Specialties, Inc. | DISCOGRAPHY KIT | 1996-03-21 | 70 |
| K960146 | GE Medical Systems | G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | 1996-02-27 | 42 |
| K913436 | Brotherston/Pxi | PXI PNEUMATIC COMPRESSION PADDLE | 1992-11-05 | 462 |
| K920393 | Shimadzu Medical Systems | MU125M MOBILE X-RAY SYSTEM | 1992-04-06 | 67 |
| K910503 | B. Braun of America, Inc. | DISCOGRAPHY KIT | 1991-10-07 | 244 |
Recalls for IZG devices
openFDA lists no recalls for product code IZG.
Frequently asked questions
What is FDA product code IZG?
IZG is the FDA product code for system, x-ray, photofluorographic. It is a Class II device, regulated under 21 CFR 892.1730 and reviewed by the Radiology panel.
What device class is IZG?
Class II, regulation 21 CFR 892.1730. Typical premarket route: 510(k).
How long does a 510(k) take for product code IZG?
Across 7 cleared submissions the average was 180 days from receipt to decision (median 155).
Which companies have the most IZG clearances?
Spinal Specialties, Inc. (1); GE Medical Systems (1); Brotherston/Pxi (1); Shimadzu Medical Systems (1); B. Braun of America, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code IZG
- Run a recall and safety report across every IZG manufacturer
- Watch product code IZG 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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