ICON
FDA 510(k) clearance K903315 · decided 1991-01-09
Clearance details
- K-number
- K903315
- Device name
- ICON
- Applicant
- Siemens Gammasonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-24
- Decision date
- 1991-01-09
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- JWM
- Device class
- 2
- Regulation number
- 892.1310
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hoffman Estates, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ICON COMPUTER SYSTEM (K914350) | Siemens Gammasonics, Inc. | 1991-11-22 |
| D2 SPECTRUM GAMMA CAMERA/CRYSTAL V COMPUTER SYSTEM (K904599) | Digital Design, Inc. | 1991-04-23 |
| GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM (K901545) | Toshiba America Medical Systems, In.C | 1990-06-26 |
| ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM (K874473) | Adac Laboratories | 1988-07-18 |
| ADAC MODEL ARC-5000, GAMMA CAMERA (K873075) | Adac Laboratories | 1987-10-30 |
| DIGITAL GAMMA CAMERA GCA 601 E (K851685) | Toshiba Medical Systems | 1985-06-14 |
| STARCAM DATA ACQUISITION & PROCESSING SYS H3300C (K850885) | General Electric Co. | 1985-06-06 |
| JUMBO DIGITAL GAMMACAMERA GCA-90B (K851687) | Toshiba Medical Systems | 1985-06-05 |
| DIGITAL GAMMA CAMERA GCA 501S (K851686) | Toshiba Medical Systems | 1985-06-05 |
| DOT-A, DOT-AR PXP-E, PXP-ER (K841905) | Siemens Gammasonics, Inc. | 1984-08-09 |
| ECT PROCESSOR (K832737) | Siemens Gammasonics, Inc. | 1983-09-29 |
| 400T ECT SOFTWARE (K812966) | General Electric Co. | 1981-11-24 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission I recall (Z-0727-03) | Siemens Medical Solutions USA, Inc. | 2003-04-16 |