Cleared Traditional

Discovery NM 750b Bopsy

K160933 · Ge Healthcare · Radiology
Nov 2016
Decision
228d
Days
Class 1
Risk

About This 510(k) Submission

K160933 is an FDA 510(k) clearance for the Discovery NM 750b Bopsy, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on November 18, 2016, 228 days after receiving the submission on April 4, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K160933 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2016
Decision Date November 18, 2016
Days to Decision 228 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYX — Camera, Scintillation (gamma)
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1100

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