510(k) K212004— MyoSPECT, MyoSpect ES

Substantially Equivalent

GE Healthcare

Clearance details

Applicant: GE Healthcare
Product code: Code KPS
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 ↗

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