FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
FDA 510(k) clearance K970293 · decided 1997-03-21
Clearance details
- K-number
- K970293
- Device name
- FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-24
- Decision date
- 1997-03-21
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LMD
- Device class
- 1
- Regulation number
- 892.2020
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Stamford, CT, 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 |
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| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FULL FIELD DIGITAL MAMMOGRAPHY (P050014/S002) | Fujifilm Medical System U.S.A., Inc. | 2009-08-11 |
| FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (P050014/S001) | Fujifilm Medical System U.S.A., Inc. | 2009-01-09 |
| FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE (FCRMS) (P050014) | Fujifilm Medical System U.S.A., Inc. | 2006-07-10 |