Cleared Traditional

K102231 - DISCOVERY NM 750B (FDA 510(k) Clearance)

K102231 · Ge Medical Systems Israel, Functional Imaging · Radiology device
Nov 2010
Decision
86d
Days
Class 1
Risk

K102231 is an FDA 510(k) clearance for the DISCOVERY NM 750B. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).

Submitted by Ge Medical Systems Israel, Functional Imaging (Tirat Hacarmel, IL). The FDA issued a Cleared decision on November 3, 2010, 86 days after receiving the submission on August 9, 2010.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number K102231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date November 03, 2010
Days to Decision 86 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