Star
FDA 510(k) K801917 · General Electric Co.
510(k) numberK801917
Submission
- Device name
- Star
- Applicant
- General Electric Co.
Walker, MI, US - Received
- August 11, 1980
- Decision date
- September 16, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914350 | Icon Computer SystemJWM · Traditional | Siemens Gammasonics, Inc. | 11/22/1991SE |
| K904599 | D2 Spectrum Gamma Camera/Crystal V Computer SystemJWM · Traditional | Digital Design, Inc. | 04/23/1991SE |
| K903315 | IconJWM · Traditional | Siemens Gammasonics, Inc. | 01/09/1991SE |
| K901545 | GCA-9300 Nuclear Tomography SystemJWM · Traditional | Toshiba America Medical Systems, In.C | 06/26/1990SE |
| K874473 | Adac Model Arc-St, PC Style Data Processing SystemJWM · Traditional | Adac Laboratories | 07/18/1988SE |
| K873075 | Adac Model ARC-5000, Gamma CameraJWM · Traditional | Adac Laboratories | 10/30/1987SE |
| K851685 | Digital Gamma Camera Gca 601 EJWM · Traditional | Toshiba Medical Systems | 06/14/1985SE |
| K850885 | Starcam Data Acquisition & Processing Sys H3300CJWM · Traditional | General Electric Co. | 06/06/1985SE |
| K851687 | Jumbo Digital Gammacamera GCA-90BJWM · Traditional | Toshiba Medical Systems | 06/05/1985SE |
| K851686 | Digital Gamma Camera Gca 501SJWM · Traditional | Toshiba Medical Systems | 06/05/1985SE |
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| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was Star cleared by the FDA?
Star (K801917) received a 510(k) decision of Substantially Equivalent on September 16, 1980, 36 days after the submission was received.
What is the product code of K801917?
The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.