Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MyoSPECT, MyoSpect ES

K-Number: K212004 · 2021-08-27

ApplicantGE Healthcare
Decision Date2021-08-27
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MyoSPECT, MyoSpect ES is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2021-08-27 under approval number K212004. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by GE Healthcare. The 510(k) number is K212004.

When was MyoSPECT, MyoSpect ES approved by the FDA?

MyoSPECT, MyoSpect ES received FDA 510(k) clearance on 2021-08-27, under approval number K212004.

What company makes MyoSPECT, MyoSpect ES?

MyoSPECT, MyoSpect ES is manufactured by GE Healthcare.

What is the FDA product code for MyoSPECT, MyoSpect ES?

The FDA product code for MyoSPECT, MyoSpect ES is KPS.

Related Clinical Trials

NCT06702917 GSI Cardiac on Revolution Apex - US RECRUITING NCT07263815 EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET ACTIVE_NOT_RECRUITING NCT07496918 Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices) RECRUITING

Other Devices by GE Healthcare

K160933Discovery NM 750b Bopsy K162268Senographe Pristina K162269Voluson E6, Voluson E8, Voluson E10 K162012CARESCAPE Central Station V2 K161567SIGNA Voyager K160937Senolris

View all 57 devices →

Related Devices (Code: KPS)

K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd. K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc. K161674QuantumCamDdd-Diagnostic A/S K162337Symbia 6.5Siemens Medical Solutions USA, Inc. K161574Discovery MIGe Medical Systems, LLC K161631MAMMIGeneral Equipment For Medical Imaging

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.

↑