MEDIPACS
FDA 510(k) clearance K950413 · decided 1995-06-30
Clearance details
- K-number
- K950413
- Device name
- MEDIPACS
- Applicant
- Nexsys Electronics
- Decision
- Substantially Equivalent
- Date received
- 1995-01-31
- Decision date
- 1995-06-30
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- LMD
- Device class
- 1
- Regulation number
- 892.2020
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Leandro, CA, US
- 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 |
|---|---|---|
| IIVS INTEGRATED IMAGE VIEWING STATION (K994329) | Terarecon,Inc. | 2000-05-26 |
| STENTOR, PAGEVIEW (K992698) | Stentor, Inc. | 1999-10-25 |
| RAYPAX WEB CLINICAL SYSTEM (K992426) | Samsung Sds Co., Ltd. | 1999-10-13 |
| ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0 (K992352) | Inteleradiology, Inc. | 1999-09-29 |
| SAMSUNG RAYPAX SYSTEM (K991537) | Samsung Sds Co., Ltd. | 1999-07-06 |
| STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM (K984000) | Surgical Navigation Technologies, Inc. | 1999-01-12 |
| IMAGEQUEST (K974707) | Visual Med, Inc. | 1998-07-31 |
| KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW (K981053) | Eastman Kodak Company | 1998-06-18 |
| JPACS (K980918) | Philips Medical Systems (Cleveland), Inc. | 1998-06-03 |
| DOWNSCAN LT (K974882) | Merlin Engineering Works, Inc. | 1998-05-22 |
| VR NETSERVE (K980684) | I.S.G. Technologies, Inc. | 1998-05-06 |
| BARCO MGD 521 5 MEGAPIXEL DIAGNOSTIC DISPLAY (K980541) | Barco NV Display Systems | 1998-04-09 |
Recalls involving this device
No recalls on record reference this clearance.