Cleared Special

K062107 - SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003 (FDA 510(k) Clearance)

K062107 · Hologic, Inc. · Radiology device

Aug 2006

Decision

25d

Days

Class 2

Risk

K062107 is an FDA 510(k) clearance for the SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on August 18, 2006, 25 days after receiving the submission on July 24, 2006.

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

Submission Details

510(k) Number	K062107 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 2006
Decision Date	August 18, 2006
Days to Decision	25 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF