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Vscan Air for Android

by GE Vingmed Ultrasound A/S

Ref Vscan Air for AndroidModel Vscan Air app for Android

Vscan Air for Android is an ultrasound imaging system application software (EU MDD Class IIa; FDA Class II) made by GE Vingmed Ultrasound A/S, registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI B-00840682147101), cleared under FDA 510(k) K202035 on 20 Nov 2020 and listed in FDA GUDID since 23 Feb 2021 (UDI-DI 00840682147101), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202035

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840682147101 Basic UDI-DI 00840682147101UDI-DIDate23 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840682147101 UDI-DI Date23 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK202035 Date20 Nov 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00840682147101 registered 23 Jun 2026 Active
  • FDA 510(k) K202035 decided 20 Nov 2020 Active
  • FDA GUDID UDI-DI 00840682147101 listed 23 Feb 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K202035
  2. Listed FDA GUDID 00840682147101
  3. Registered EUDAMED B-00840682147101

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Vscan Air EUDAMED
Vscan GUDID
Generic name
Ultrasound imaging system application software
Model / reference
Vscan Air app for Android EUDAMED
Vscan Air for Android EUDAMED
Air for Android GUDID
Primary DI / UDI-DI
00840682147101
Basic UDI-DI
B-00840682147101
510(k) Number
FDA product code
ITX, IYO, IYN
EMDN code
Z11040192 Ultrasound scanners - medical device software
GMDN term
Ultrasound imaging system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1560, 892.1550
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Vscan Air app for Android
Vscan Air for Android
GUDID
Air for Android
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Ultrasound imaging system application software

Cleared under the same submission (K202035)

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE.

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See all devices from GE Vingmed Ultrasound A/S →

Properties

  • Measuring function
  • Lot / batch number
Other properties (21, all answered No)