IZG
7 FDA 510(k) clearances · Product code
155 daysmedian time to decision
462 days90th percentile
7clearances measured
FDA profile
- Official device name
- System, X-Ray, Photofluorographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1730
- Medical specialty
- Radiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1998: 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 |
|---|---|---|
| DISCOGRAPHY KIT (K960082) | Spinal Specialties, Inc. | 1996-03-21 |
| G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY (K960146) | GE Medical Systems | 1996-02-27 |
| PXI PNEUMATIC COMPRESSION PADDLE (K913436) | Brotherston/Pxi | 1992-11-05 |
| MU125M MOBILE X-RAY SYSTEM (K920393) | Shimadzu Medical Systems | 1992-04-06 |
| DISCOGRAPHY KIT (K910503) | B. Braun of America, Inc. | 1991-10-07 |
| AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT (K903808) | Advanced Med/Surg, Inc. | 1991-01-22 |
| ELECTRODELCA (K892659) | Oldelft Corp. of America | 1989-11-21 |
Track IZG automatically
Every clearance here is in the API, with alerts when new ones post.