Siemens Orthophos Ds/Ds Ceph
FDA 510(k) K972312 · Siemens AG
510(k) numberK972312
Submission
- Device name
- Siemens Orthophos Ds/Ds Ceph
- Applicant
- Siemens AG
North Attleboro, MA, US - Received
- June 20, 1997
- Decision date
- September 15, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Siemens Orthophos Ds/Ds Ceph cleared by the FDA?
Siemens Orthophos Ds/Ds Ceph (K972312) received a 510(k) decision of Substantially Equivalent on September 15, 1997, 87 days after the submission was received.
What is the product code of K972312?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.