510(k) K111304
- Device
- OPTIMA XR120
- Applicant
- GE MEDICAL SYSTEMS, LLC
- 510(k) number
- K111304
- Product code
- IXL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-07-19
- Date received
- 2011-05-09
- Regulation
- 892.1670
- Classification name
- Device, Spot-film
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- NIDHI CHAUDHARY
- Address
- 3000 N. Grandview Blvd. Waukesha WI US 53188 53188
FDA Registration Numbers#
- 3015276088
- 3033525986
- 3000126629
- 3003768251
- 3033527770
- 8021091
Source Documents#
Other 510(k) Records For Product Code IXL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K964806 | MD-1835 | Fischer Imaging Corp. | 1997-03-04 |
| K950317 | ADVANTX 1824 SPOTFILM DEVICE | GE Medical Systems | 1995-02-08 |
| K940386 | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | Eastman Kodak Company | 1994-08-17 |
| K942367 | AXT 1400 SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | 1994-06-06 |
| K924593 | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 | Philips Medical Systems, Inc. | 1992-11-24 |
| K902403 | ELITE R/F SPOT FILM DRIVE | Rms Div. | 1990-08-01 |
| K902146 | SFD-035 SPOT FILM DEVICE | Rms Div. | 1990-05-31 |
| K882492 | A.X.T. SPOTFILM DEVICE | Applied X-Ray Technologies, Inc. | 1988-07-21 |
| K881589 | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 | Continental X-Ray Corp. | 1988-07-18 |
| K842184 | SPOT-FILM DEVICE 8835 | General Electric Co. | 1984-07-17 |
| K802888 | RAYTHEON MEDICAL IMAGING | Machlett Laboratories, Inc. | 1981-01-09 |
| K800554 | MULTI-FORMAT SFD MODEL 1720 | Philips Medical Systems (Cleveland), Inc. | 1980-04-10 |
Legacy Summary#
summary
FDA Review#
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