JWM — System, Tomographic, Nuclear Class II
FDA product code JWM covers "System, Tomographic, Nuclear", a Class II medical device regulated under 21 CFR 892.1310. Submissions are reviewed by the Radiology panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JWM
- Device Class
- Class II
- Regulation Number
- 892.1310
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K914350 | siemens gammasonics | ICON COMPUTER SYSTEM | November 22, 1991 |
| K904599 | digital design | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM | April 23, 1991 |
| K903315 | siemens gammasonics | ICON | January 9, 1991 |
| K901545 | toshiba america medical systems, in.c | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM | June 26, 1990 |
| K874473 | adac laboratories | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM | July 18, 1988 |
| K873075 | adac laboratories | ADAC MODEL ARC-5000, GAMMA CAMERA | October 30, 1987 |
| K851685 | toshiba medical systems | DIGITAL GAMMA CAMERA GCA 601 E | June 14, 1985 |
| K850885 | general electric | STARCAM DATA ACQUISITION & PROCESSING SYS H3300C | June 6, 1985 |
| K851686 | toshiba medical systems | DIGITAL GAMMA CAMERA GCA 501S | June 5, 1985 |
| K851687 | toshiba medical systems | JUMBO DIGITAL GAMMACAMERA GCA-90B | June 5, 1985 |
| K841905 | siemens gammasonics | DOT-A, DOT-AR PXP-E, PXP-ER | August 9, 1984 |
| K832737 | siemens gammasonics | ECT PROCESSOR | September 29, 1983 |
| K812966 | general electric | 400T ECT SOFTWARE | November 24, 1981 |
| K810873 | intl. general electric | STAR | April 23, 1981 |
| K801917 | general electric | STAR | September 16, 1980 |
| K780369 | medtronic vascular | MODUMED MUGE | March 14, 1978 |
| K780368 | medtronic vascular | MODUMED MUGX | March 14, 1978 |