Cleared Traditional

K041555 - SECURVIEW DX SOFTCOPY WORKSTATION (FDA 510(k) Clearance)

K041555 · Hologic, Inc. · Radiology device

Aug 2004

Decision

60d

Days

Class 2

Risk

K041555 is an FDA 510(k) clearance for the SECURVIEW DX SOFTCOPY WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on August 9, 2004, 60 days after receiving the submission on June 10, 2004.

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

Submission Details

510(k) Number	K041555 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 10, 2004
Decision Date	August 09, 2004
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF