Digispot Imager
FDA 510(k) K871778 · Siemens Gammasonics, Inc.
510(k) numberK871778
Submission
- Device name
- Digispot Imager
- Applicant
- Siemens Gammasonics, Inc.
Des Plaines, IL, US - Received
- May 6, 1987
- Decision date
- May 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Digispot Imager cleared by the FDA?
Digispot Imager (K871778) received a 510(k) decision of Substantially Equivalent on May 29, 1987, 23 days after the submission was received.
What is the product code of K871778?
The FDA product code is LMC – Camera, Multi Format, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2040.