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ROTATING GAMMA SYSTEM INFINI (INFINI)

K102533 Class II Traditional
Decision Date
2011-03-22
Sponsor / Applicant
Masep Medical Science & Tech.Development (Shenzhen

Technical Specification

510(k) Submission ID K102533
Product Code IWB
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.5750
Decision Date 2011-03-22
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ROTATING GAMMA SYSTEM INFINI (INFINI) received FDA 510(k) clearance under submission number K102533, sponsored by Masep Medical Science & Tech.Development (Shenzhen. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-03-22.

Classification & Regulation

This clearance is catalogued under FDA product code IWB and 21 CFR 892.5750, within the Radiology review panel as a Class II device.