System, X-Ray, Photofluorographic
Regulation 892.1730
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IZG
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Med/Surg, Inc. | 1 | 0 |
| B. Braun of America, Inc. | 1 | 0 |
| Brotherston/Pxi | 1 | 0 |
| GE Medical Systems | 1 | 0 |
| Oldelft Corp. of America | 1 | 0 |
| Shimadzu Medical Systems | 1 | 0 |
| Spinal Specialties, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 21, 1996 | K960082 | DISCOGRAPHY KIT Spinal Specialties, Inc. | IZG |
| Feb 27, 1996 | K960146 | G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY GE Medical Systems | IZG |
| Nov 5, 1992 | K913436 | PXI PNEUMATIC COMPRESSION PADDLE Brotherston/Pxi | IZG |
| Apr 6, 1992 | K920393 | MU125M MOBILE X-RAY SYSTEM Shimadzu Medical Systems | IZG |
| Oct 7, 1991 | K910503 | DISCOGRAPHY KIT B. Braun of America, Inc. | IZG |
| Jan 22, 1991 | K903808 | AMSIS RDS, RADIOGRAPHIC DISCOGRAPHY KIT Advanced Med/Surg, Inc. | IZG |
| Nov 21, 1989 | K892659 | ELECTRODELCA Oldelft Corp. of America | IZG |
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