PHILIPS EASY DIAGNOST
FDA 510(k) clearance K970640 · decided 1997-03-21
Clearance details
- K-number
- K970640
- Device name
- PHILIPS EASY DIAGNOST
- Applicant
- Philips Medical Systems North America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-20
- Decision date
- 1997-03-21
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- IXR
- Device class
- 2
- Regulation number
- 892.1980
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shelton, CT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| TILTING RADIOGRAPHIC TABLE (REMOTE) (K963851) | Acoma Medical Imaging, Inc. | 1997-01-23 |
| TANGENT VI TABLE (K961022) | Fischer Imaging Corp. | 1996-05-03 |
| COMPAX 90/15E (K954356) | General Electric Co. | 1995-10-07 |
| SURGICAL C-ARM TABLE, 9610 (K953557) | U.S. Imaging Tables, Inc. | 1995-09-26 |
| VACS TABLE, 9650 (K953556) | U.S. Imaging Tables, Inc. | 1995-09-26 |
| KOORDINAT M (K951176) | Siemens Medical Solutions USA, Inc. | 1995-04-20 |
| ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 (K950981) | Biodex Medical Systems, Inc. | 1995-04-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 70603 recall (Z-2208-2012) | Philips Healthcare Inc. | 2012-08-15 |
| Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system recall (Z-1821-2012) | Philips Healthcare Inc. | 2012-06-18 |
| EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film opt recall (Z-2405-2010) | Philips Medical Systems North America Co. Phillips | 2010-09-13 |
| EasyDiagnost. Multi-functional R/F systems used for general R/F, Fluoroscopy, Radiography recall (Z-0849-2010) | Philips Medical Systems North America Co. Phillips | 2010-03-23 |
| Philips Easy Diagnost X-Ray System recall (Z-0909-2007) | Philips Medical Systems North America Co. Phillips | 2007-09-25 |