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Vscan Air CL A1

by GE Vingmed Ultrasound A/S

Vscan Air CL A1 is a hand-held ultrasound imaging system (FDA Class II) made by GE Vingmed Ultrasound A/S, cleared under FDA 510(k) K202035 on 20 Nov 2020 and listed in FDA GUDID since 11 Feb 2021 (UDI-DI 00840682147484), active as of 23 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 23 Oct 2026

Documents

510(k) K202035

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682147484 UDI-DI Date11 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK202035 Date20 Nov 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K202035 decided 20 Nov 2020 Active
  • FDA GUDID UDI-DI 00840682147484 listed 11 Feb 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K202035
  2. Listed FDA GUDID 00840682147484

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vscan
Generic name
Hand-held ultrasound imaging system, body-surface
Model / reference
Air CL A1
Primary DI / UDI-DI
00840682147484
510(k) Number
FDA product code
IYO, ITX, IYN
GMDN term
Hand-held ultrasound imaging system, body-surface
Device class
Class II
Regulation number
892.1560, 892.1570, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hand-held ultrasound imaging system, body-surface

Cleared under the same submission (K202035)

Similar devices in this category

Other devices filed under Hand-held ultrasound imaging system, body-surface.

Other devices from GE Vingmed Ultrasound A/S

  • Vivid Focus

    Class II

  • Vivid Explorer

    Class II

  • Vivid Advanced

    Class II

  • Vivid E90 v202

    Class II

See all devices from GE Vingmed Ultrasound A/S →

Properties

  • Serial number
Other properties (14, all answered No)