Somatom Plus 4 with Sliding Gantry Option
FDA 510(k) K991600 · Siemens Corp.
510(k) numberK991600
Submission
- Device name
- Somatom Plus 4 with Sliding Gantry Option
- Applicant
- Siemens Corp.
Iselin, NJ, US - Received
- May 10, 1999
- Decision date
- June 9, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Somatom Plus 4 with Sliding Gantry Option cleared by the FDA?
Somatom Plus 4 with Sliding Gantry Option (K991600) received a 510(k) decision of Substantially Equivalent on June 9, 1999, 30 days after the submission was received.
What is the product code of K991600?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.