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TargetScan Touch 001-A100

by Best Nomos

TargetScan Touch 001-A100 is a Class II device made by Best Nomos, cleared under FDA 510(k) K041639 on 2 Sep 2004 and listed in FDA GUDID since 31 Oct 2016 (UDI-DI 00852656007069), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K041639

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 Number00852656007069 UDI-DI Date31 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041639 Date2 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041639 decided 2 Sep 2004 Active
  • FDA GUDID UDI-DI 00852656007069 listed 31 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K041639
  2. Listed FDA GUDID 00852656007069

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TargetScan Touch
Generic name
General-purpose ultrasound imaging system
Model / reference
001-A100
Primary DI / UDI-DI
00852656007069
510(k) Number
FDA product code
ITX, IYO
GMDN term
General-purpose ultrasound imaging system
Device class
Class II
Regulation number
892.1570, 892.1560
GUDID distribution status
In Commercial Distribution

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Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)