GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
FDA 510(k) clearance K873121 · decided 1988-08-23
Clearance details
- K-number
- K873121
- Device name
- GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
- Applicant
- General Electric Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-08-11
- Decision date
- 1988-08-23
- Days to decision
- 378 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
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| STENTOR, PAGEVIEW (K992698) | Stentor, Inc. | 1999-10-25 |
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| 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 |
|---|---|---|
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017) | General Electric Co. | 1988-07-29 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013) | General Electric Co. | 1988-07-15 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016) | General Electric Co. | 1988-06-30 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014) | General Electric Co. | 1988-05-05 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015) | General Electric Co. | 1988-05-02 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012) | General Electric Co. | 1987-11-25 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011) | General Electric Co. | 1987-06-18 |
| GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010) | General Electric Co. | 1987-03-30 |