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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 15, 2004 | K042733 | STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM Standard Imaging, Inc. | LHO |
| Oct 30, 1987 | K873956 | ULTIMETER Radiation Measurements, Inc. | LHO |
| May 7, 1986 | K860260 | MULTI PURPOSE MODEL 76-903 Victoreen, Inc. | LHO |
| May 7, 1986 | K853754 | MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 Victoreen, Inc. | LHO |
| Apr 22, 1986 | K860100 | MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 Victoreen, Inc. | LHO |
| Jul 1, 1985 | K845007 | RFA-7 RADIATION FIELD ANALYZER Varian Assoc., Inc. | LHO |
| Jul 1, 1985 | K844620 | BDS-3 BEAM DATA SCANNER Varian Assoc., Inc. | LHO |
| Mar 5, 1984 | K834483 | DIGI-X Radiation Measurements, Inc. | LHO |
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