UNIVERSIX 190
FDA 510(k) clearance K953402 · decided 1995-08-11
Clearance details
- K-number
- K953402
- Device name
- UNIVERSIX 190
- Applicant
- Philips Medical Systems (Cleveland), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-20
- Decision date
- 1995-08-11
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- IXY
- Device class
- 1
- Regulation number
- 892.1880
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| VRS 3 WALL STAND (K953336) | Philips Medical Systems (Cleveland), Inc. | 1995-08-11 |
| SENSORI-MOTOR RATING SCALE (K946114) | Cmed | 1995-04-28 |
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| BC/WT/PF (K930249) | Tingle X-Ray Products, Inc. | 1993-04-27 |
| WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (K925934) | Continental X-Ray Corp. | 1993-03-04 |
| BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY (K924445) | Control-X, Inc. | 1993-02-19 |
| VERT-X UNIVERSAL VERTICAL BUCKY STAND (K922443) | Afp Imaging Corp. | 1992-10-26 |
| MODEL H170 PEDIATRIC CHEST X-RAY UNIT (K915667) | H.L. Lyons Co. | 1992-01-31 |
| BUCKYS MODELS YMB-15A, YMB-15B AND YMB-15C (K895034) | Yamato Medical Corp. | 1989-11-15 |
| RADKOR BS-10 AND BS-10T (K891395) | Radkor, Inc. | 1989-04-03 |
| SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS (K872132) | Sopha Medical Systems, Inc. | 1987-10-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S019) | Philips Medical Systems (Cleveland), Inc. | 1988-07-27 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S022) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S021) | Philips Medical Systems (Cleveland), Inc. | 1988-07-14 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S018) | Philips Medical Systems (Cleveland), Inc. | 1988-06-13 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S017) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S015) | Philips Medical Systems (Cleveland), Inc. | 1988-05-16 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S016) | Philips Medical Systems (Cleveland), Inc. | 1988-04-28 |
| NUCLEAR MAGNETIC RESONANCE SCANNER MODELS NMR 1000 (P830052/S014) | Philips Medical Systems (Cleveland), Inc. | 1988-04-26 |