400T Ect Software
FDA 510(k) K812966 · General Electric Co.
510(k) numberK812966
Submission
- Device name
- 400T Ect Software
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- October 22, 1981
- Decision date
- November 24, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JWM
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|---|---|---|---|
| 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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Questions and answers
When was 400T Ect Software cleared by the FDA?
400T Ect Software (K812966) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 33 days after the submission was received.
What is the product code of K812966?
The FDA product code is JWM – System, Tomographic, Nuclear, a Class II (moderate risk) device regulated under 21 CFR 892.1310.