MyoSPECT, MyoSpect ES— 510(k) K212004

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K212004 for MyoSPECT, MyoSpect ES, Substantially Equivalent on 2021-08-27. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2021-06-28
Decision date: 2021-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tirat Hacarmel, IL

Download summary PDF View on FDA.gov ↗

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Recalls naming K212004

K-number listed on FDA's recall record

Z-2040-2024 — MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H3912AB and H3912BD, dedicated cardiac SPECT (single photon emission computerized tomography system).Class II·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·20240415

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K212004.

Data sourced from openFDA. This site is unofficial and independent of the FDA.