FDA Product Code
FDA Product Code JWM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1310
510(k) Clearances — 17 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K914350 | ICON COMPUTER SYSTEM | Siemens Gammasonics, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K904599 | D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM | Digital Design, Inc. | 1991-04-23 | Traditional | PDF ↗ |
| K903315 | ICON | Siemens Gammasonics, Inc. | 1991-01-09 | Traditional | PDF ↗ |
| K901545 | GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM | Toshiba America Medical Systems, In.C | 1990-06-26 | Traditional | PDF ↗ |
| K874473 | ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM | Adac Laboratories | 1988-07-18 | Traditional | PDF ↗ |
| K873075 | ADAC MODEL ARC-5000, GAMMA CAMERA | Adac Laboratories | 1987-10-30 | Traditional | PDF ↗ |
| K851685 | DIGITAL GAMMA CAMERA GCA 601 E | Toshiba Medical Systems | 1985-06-14 | Traditional | PDF ↗ |
| K850885 | STARCAM DATA ACQUISITION & PROCESSING SYS H3300C | General Electric Co. | 1985-06-06 | Traditional | PDF ↗ |
| K851687 | JUMBO DIGITAL GAMMACAMERA GCA-90B | Toshiba Medical Systems | 1985-06-05 | Traditional | PDF ↗ |
| K851686 | DIGITAL GAMMA CAMERA GCA 501S | Toshiba Medical Systems | 1985-06-05 | Traditional | PDF ↗ |
| K841905 | DOT-A, DOT-AR PXP-E, PXP-ER | Siemens Gammasonics, Inc. | 1984-08-09 | Traditional | PDF ↗ |
| K832737 | ECT PROCESSOR | Siemens Gammasonics, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K812966 | 400T ECT SOFTWARE | General Electric Co. | 1981-11-24 | Traditional | PDF ↗ |
| K810873 | STAR | Intl. General Electric Co. | 1981-04-23 | Traditional | PDF ↗ |
| K801917 | STAR | General Electric Co. | 1980-09-16 | Traditional | PDF ↗ |
| K780368 | MODUMED MUGX | Medtronic Vascular | 1978-03-14 | Traditional | PDF ↗ |
| K780369 | MODUMED MUGE | Medtronic Vascular | 1978-03-14 | Traditional | PDF ↗ |
Product code JWM · Class II · Radiology. Data: openFDA.