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 | Nov 22, 1991 |
| K904599 | Digital Design | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM | Apr 23, 1991 |
| K903315 | Siemens Gammasonics | ICON | Jan 9, 1991 |
| K901545 | Toshiba America Medical Systems, In.C | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM | Jun 26, 1990 |
| K874473 | Adac Laboratories | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM | Jul 18, 1988 |
| K873075 | Adac Laboratories | ADAC MODEL ARC-5000, GAMMA CAMERA | Oct 30, 1987 |
| K851685 | Toshiba Medical Systems | DIGITAL GAMMA CAMERA GCA 601 E | Jun 14, 1985 |
| K850885 | General Electric | STARCAM DATA ACQUISITION & PROCESSING SYS H3300C | Jun 6, 1985 |
| K851687 | Toshiba Medical Systems | JUMBO DIGITAL GAMMACAMERA GCA-90B | Jun 5, 1985 |
| K851686 | Toshiba Medical Systems | DIGITAL GAMMA CAMERA GCA 501S | Jun 5, 1985 |
| K841905 | Siemens Gammasonics | DOT-A, DOT-AR PXP-E, PXP-ER | Aug 9, 1984 |
| K832737 | Siemens Gammasonics | ECT PROCESSOR | Sep 29, 1983 |
| K812966 | General Electric | 400T ECT SOFTWARE | Nov 24, 1981 |
| K810873 | Intl. General Electric | STAR | Apr 23, 1981 |
| K801917 | General Electric | STAR | Sep 16, 1980 |
| K780369 | Medtronic Vascular | MODUMED MUGE | Mar 14, 1978 |
| K780368 | Medtronic Vascular | MODUMED MUGX | Mar 14, 1978 |