MyoSPECT, MyoSpect ES
K-Number: K212004 · 2021-08-27
Device Summary
Frequently Asked Questions
What is the MyoSPECT, MyoSpect ES?
MyoSPECT, MyoSpect ES is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is GE Healthcare. The 510(k) number is K212004.
When did MyoSPECT, MyoSpect ES receive FDA 510(k) clearance?
MyoSPECT, MyoSpect ES received FDA 510(k) clearance on 2021-08-27, under 510(k) number K212004.
Who is the listed applicant for MyoSPECT, MyoSpect ES?
The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MyoSPECT, MyoSpect ES?
The FDA product code for MyoSPECT, MyoSpect ES is KPS.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing GE Healthcare as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: KPS)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.