Cleared Traditional

K061671 - SYNGO TRUED, MODEL VC10A (FDA 510(k) Clearance)

K061671 · Siemens Medical Solutions · Radiology device

Jun 2006

Decision

15d

Days

Class 2

Risk

K061671 is an FDA 510(k) clearance for the SYNGO TRUED, MODEL VC10A. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on June 29, 2006, 15 days after receiving the submission on June 14, 2006.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K061671 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 14, 2006
Decision Date	June 29, 2006
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF