PHILIPS SUPER CP FAMILY
FDA 510(k) clearance K925844 · decided 1992-12-28
Clearance details
- K-number
- K925844
- Device name
- PHILIPS SUPER CP FAMILY
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-18
- Decision date
- 1992-12-28
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- IZO
- Device class
- 1
- Regulation number
- 892.1700
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MPH50, MPH65, AND MPH80 (K954666) | GE Medical Systems | 1995-11-24 |
| HFX350, 30KW, 300MA, 1 OR 3 PHASE RADIOGRAPHIC & FLUOROSCOPIC X-RAY GENERATOR (K953582) | Varian Canada, Inc. | 1995-09-26 |
| N 800 HF (K953831) | Nucletron-Oldelft Corp. | 1995-09-08 |
| SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (K952822) | Shimadzu Corp. | 1995-07-12 |
| MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR (K952265) | Control-X, Inc. | 1995-07-06 |
| POLYDOROS SX 65 AND 80 (K950883) | Siemens Medical Solutions USA, Inc. | 1995-04-03 |
| COMPACT-X (K950694) | Electromed Intl., Ltd. | 1995-03-31 |
| DIGITAL 625HF (K950291) | Fischer Imaging Corp. | 1995-03-23 |
| UD 150L-R II (K945453) | Shimadzu Medical Systems | 1995-03-21 |
| SII 525 APR (K950040) | Scott Imaging Intl., Inc. | 1995-03-21 |
| SII 360 APR (K950041) | Scott Imaging Intl., Inc. | 1995-03-21 |
| UD 150L-F (K945452) | Shimadzu Medical Systems | 1995-03-21 |
Recalls involving this device
No recalls on record reference this clearance.