IXL — Device, Spot-Film Class II
FDA product code IXL covers "Device, Spot-Film", a Class II medical device regulated under 21 CFR 892.1670. Submissions are reviewed by the Radiology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IXL
- Device Class
- Class II
- Regulation Number
- 892.1670
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K111304 | ge medical systems | OPTIMA XR120 | July 19, 2011 |
| K964806 | fischer imaging | MD-1835 | March 4, 1997 |
| K950317 | ge medical systems | ADVANTX 1824 SPOTFILM DEVICE | February 8, 1995 |
| K940386 | eastman kodak | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP | August 17, 1994 |
| K942367 | applied x-ray technologies | AXT 1400 SPOTFILM DEVICE | June 6, 1994 |
| K924593 | philips medical systems | DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4 | November 24, 1992 |
| K902403 | rms div | ELITE R/F SPOT FILM DRIVE | August 1, 1990 |
| K902146 | rms div | SFD-035 SPOT FILM DEVICE | May 31, 1990 |
| K882492 | applied x-ray technologies | A.X.T. SPOTFILM DEVICE | July 21, 1988 |
| K881589 | continental x-ray | 14X14 MULTIFORMAT SPOT FILMER, NO. 6650.400 | July 18, 1988 |
| K842184 | general electric | SPOT-FILM DEVICE 8835 | July 17, 1984 |
| K802888 | machlett laboratories | RAYTHEON MEDICAL IMAGING | January 9, 1981 |
| K800554 | philips medical systems (cleveland) | MULTI-FORMAT SFD MODEL 1720 | April 10, 1980 |