Programmer, Changer, Film/Cassette, Radiographic
Regulation 892.1870
0510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IZP
| Company | 510(k)s | Recalls |
|---|---|---|
| Elema-Schonander, Inc. | 4 | 0 |
| Cgr Medical Corp. | 1 | 0 |
| Changer Service & Engineering, Inc. | 1 | 0 |
| Mallinckrodt Group, Inc. | 1 | 0 |
| Medrad, Inc. | 1 | 0 |
| Philips Medical Systems North America, Inc. | 1 | 0 |
| Sybron Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 15, 1993 | K934944 | MPQ-42 Elema-Schonander, Inc. | IZP |
| Oct 15, 1991 | K911888 | PHILIPS ANGIOPRO Philips Medical Systems North America, Inc. | IZP |
| Dec 13, 1990 | K904144 | PULMOVISION CHEST RADIOGRAPHY X-RAY SYSTEM Mallinckrodt Group, Inc. | IZP |
| Nov 20, 1990 | K904103 | SEP 90 Elema-Schonander, Inc. | IZP |
| Feb 11, 1988 | K874451 | OMNIPLANE 200 FILM CHANGER SYSTEM Medrad, Inc. | IZP |
| Oct 28, 1985 | K854251 | THE CSE FILM CHANGER SYSTEM Changer Service & Engineering, Inc. | IZP |
| Aug 21, 1984 | K842903 | SEP PROGRAMMER FOR PUCK U & UD FILMCHANG Elema-Schonander, Inc. | IZP |
| Jun 5, 1984 | K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM Sybron Corp. | IZP |
| Jun 5, 1984 | K841649 | MAXIMAX - 4 Cgr Medical Corp. | IZP |
| Feb 21, 1984 | K840389 | SEP PROGRAMMER SEP-M/SINGLE-PLANE & Elema-Schonander, Inc. | IZP |
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