Somatom 2
FDA 510(k) K790975 · Siemens Corp.
510(k) numberK790975
Submission
- Device name
- Somatom 2
- Applicant
- Siemens Corp.
Walker, MI, US - Received
- May 23, 1979
- Decision date
- July 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K071310 | Syngo CT Oncology Software PackageJAK · Traditional | 06/08/2007SE |
| K063507 | Syngo Neuro PBV CTJAK · Traditional | 11/30/2006SE |
| K063373 | Flex Loop Coil Set 3TMOS · Traditional | 11/17/2006SE |
| K053024 | Syngo Neuro Dsa CTJAK · Traditional | 11/04/2005SE |
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Questions and answers
When was Somatom 2 cleared by the FDA?
Somatom 2 (K790975) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 68 days after the submission was received.
What is the product code of K790975?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.