GE ADVANTAGE DIGITIZER WORKSTATION
FDA 510(k) clearance K970628 · decided 1997-05-12
Clearance details
- K-number
- K970628
- Device name
- GE ADVANTAGE DIGITIZER WORKSTATION
- Applicant
- Ge Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-02-19
- Decision date
- 1997-05-12
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LMD
- Device class
- 1
- Regulation number
- 892.2020
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge 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 |
|---|---|---|
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011) | Ge Medical Systems, Inc. | 2012-10-10 |
| FETAL ACOUSTIC STIMULATOR (P870025/S010) | Ge Medical Systems, Inc. | 2011-10-12 |
| FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009) | Ge Medical Systems, Inc. | 2010-04-23 |
| FETAL ACOUSTIC STIMULATOR (P870025/S008) | Ge Medical Systems, Inc. | 2006-03-02 |
| COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007) | Ge Medical Systems, Inc. | 2005-03-24 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006) | Ge Medical Systems, Inc. | 2001-11-09 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005) | Ge Medical Systems, Inc. | 1996-07-17 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004) | Ge Medical Systems, Inc. | 1996-02-01 |