Cleared Traditional

MyoSPECT, MyoSpect ES

K212004 · Ge Healthcare · Radiology
Aug 2021
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K212004 is an FDA 510(k) clearance for the MyoSPECT, MyoSpect ES, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Ge Healthcare (Tirat Hacarmel, IL). The FDA issued a Cleared decision on August 27, 2021, 60 days after receiving the submission on June 28, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K212004 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2021
Decision Date August 27, 2021
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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