PHILIPS THORAVISION
FDA 510(k) clearance K931071 · decided 1994-09-15
Clearance details
- K-number
- K931071
- Device name
- PHILIPS THORAVISION
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-02
- Decision date
- 1994-09-15
- Days to decision
- 562 days
- Clearance type
- Traditional
- Product code
- KPR
- Device class
- 2
- Regulation number
- 892.1680
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Philips Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DRE Duo (K260482) | Jpi Healthcare Co, Ltd. | 2026-06-15 |
| AeroDR TX c02 (K253446) | Dk Medical Systems Co., Ltd. | 2026-04-10 |
| DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector (K250954) | Carestream Health | 2026-01-20 |
| uDR Arria & uDR Aris (K252000) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-11-26 |
| uDR Aurora CX (K251167) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-09-19 |
| Definium Tempo Select (K250788) | Ge Hualun Medical Systems Co. , Ltd. | 2025-08-28 |
| INNOVISION-DXII (K250790) | Dk Medical Systems Co., Ltd. | 2025-08-01 |
| YSIO X.pree (K250738) | Siemens Medical Solutions | 2025-07-31 |
| GXR-Series Diagnostic X-Ray System (K242019) | DRGEM Corporation | 2025-01-07 |
| Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 |
| INNOVISION-EXII (K242119) | Dk Medical System | 2025-01-03 |
| uDR 780i (K241068) | Shanghai United Imaging Healthcare Co., Ltd. | 2024-11-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811 recall (Z-0369-05) | Philips Medical Systems Sales & Service Region No. America | 2004-12-24 |