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Second Look Viewer

by Icad, Inc.

510(k) K042697

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042697 Date19 Nov 2004ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Second Look Viewer is a Picture Archiving and Communication System (PACS) device (21 CFR 892.2050) designed for post-procedural radiographic review. It enables radiologists to assess surgical outcomes by comparing pre- and post-operative images, particularly in orthopedic and trauma cases, to confirm retention or placement of surgical hardware such as screws, plates, or implants.

This device is supplied as a reusable, non-sterile system intended for use in radiology departments. It operates within standard MRI-safe environments and is cleared under FDA 510(k) clearance (K042697) for Class II medical devices. Storage and handling follow manufacturer guidelines to ensure image integrity and device functionality, with no specified sterility requirements beyond standard radiology protocols.

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