Discovery NM 750b Bopsy
FDA 510(k) K160933 · GE Healthcare
510(k) numberK160933
Submission
- Device name
- Discovery NM 750b Bopsy
- Applicant
- GE Healthcare
Tirat Hacarmel, IL - Received
- April 4, 2016
- Decision date
- November 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Discovery NM 750b Bopsy cleared by the FDA?
Discovery NM 750b Bopsy (K160933) received a 510(k) decision of Substantially Equivalent on November 18, 2016, 228 days after the submission was received.
What is the product code of K160933?
The FDA product code is IYX – Camera, Scintillation (Gamma), a Class I (low risk) device regulated under 21 CFR 892.1100.