System, Therapeutic, X-Ray
Regulation 892.5900
1510(k)s in 12 months (53 all time)
1recalls in 12 months (12 all time)
12recalls that name a 510(k)
Top companies in JAD
| Company | 510(k)s | Recalls |
|---|---|---|
| Carl Zeiss Meditec, AG | 4 | 6 |
| Sensus Healthcare | 6 | 1 |
| Xoft, Inc. | 5 | 0 |
| Xstrahl, Ltd. | 2 | 3 |
| Action Products, Inc. | 1 | 2 |
| Carl Zeiss Surgical GmbH | 3 | 0 |
| Icad, Inc. | 3 | 0 |
| Adac Laboratories | 2 | 0 |
| Emi Therapy Systems, Inc. | 2 | 0 |
| Nucletron B.V. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 2, 1978 | K780278 | RADIATION THERAPY TREAT. PLAN. SYS. Pfizer Medical Systems, Inc. | JAD |
| Feb 13, 1978 | K780157 | RADIATION TREATMENT PLANNING SYSTEM Capintec, Inc. | JAD |
| Jan 13, 1978 | K771817 | EMI THERAPY SIMULATOR Emi Therapy Systems, Inc. | JAD |
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