meddevicedb.com FDA Device Reference

SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)

K052775 Class II Traditional
Decision Date
2005-10-31
Sponsor / Applicant
Siemens AG Medical Solutions

Technical Specification

510(k) Submission ID K052775
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2005-10-31
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP) received FDA 510(k) clearance under submission number K052775, 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 2005-10-31.

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.