Instrument, Quality-Assurance, Radiologic
Regulation 892.1940
0510(k)s in 12 months (8 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LHO
| Company | 510(k)s | Recalls |
|---|---|---|
| Victoreen, Inc. | 3 | 0 |
| Radiation Measurements, Inc. | 2 | 0 |
| Varian Assoc., Inc. | 2 | 0 |
| Landauer | 0 | 1 |
| Mevion Medical Systems, Inc. | 0 | 1 |
| Standard Imaging, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2024 | Landauer microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000, BC30058, and BC30059 Completed |
LHO | None listed |
| Jun 23, 2020 | Mevion Medical Systems, Inc. MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients Terminated |
LHO | K120676 |
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