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SYNGO IMAGING (VERSION V31)

K081734 Class II Traditional
Decision Date
2008-07-03
Sponsor / Applicant
Siemens AG Medical Solutions

Technical Specification

510(k) Submission ID K081734
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2008-07-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SYNGO IMAGING (VERSION V31) received FDA 510(k) clearance under submission number K081734, sponsored by Siemens AG Medical Solutions. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-07-03.

Classification & Regulation

This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.