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SecondLook Digital (SLD) V7.2

by Icad, Inc.

SecondLook Digital (SLD) V7.2 (DS0206) is a basic x-ray clinical assessment support software (FDA Class II; FDA product code MYN, Analyzer,Medical Image) made by Icad, Inc., approved under FDA PMA P010038 on 15 Jan 2002 and listed in FDA GUDID since 22 Sep 2014 (UDI-DI 00858012005007), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P010038

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858012005007 UDI-DI Date22 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP010038 Date15 Jan 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P010038 decided 15 Jan 2002 Active
  • FDA GUDID UDI-DI 00858012005007 listed 22 Sep 2014 Listed

Timeline

2 dated events

  1. Approved FDA PMA P010038
  2. Listed FDA GUDID 00858012005007

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
SecondLook Digital (SLD)
Generic name
Basic x-ray clinical assessment support software
Model / Ref / Catalog
V7.2, DS0206
Primary DI / UDI-DI
00858012005007
PMA number
FDA product code
MYN
GMDN term
Basic x-ray clinical assessment support software
Device class
Class II
Regulation number
892.2070
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Basic diagnostic x-ray system application software.

Other devices from Icad, Inc.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)