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Kosmos Software [Android]

by EchoNous

Part of a family of 31 devices: see the family page

Ref P006576

Kosmos Software [Android] (P006576) is a device classified as Class IIa in the EU and Class II in the US made by EchoNous, registered in EUDAMED on 29 Oct 2021 (Basic UDI-DI 93532780KOSMOSWH), cleared under FDA 510(k) K212100 on 6 Aug 2021 (1 earlier submission) and listed in FDA GUDID since 27 Oct 2021 (UDI-DI 09353278000588), withdrawn (EUDAMED), active (FDA 510(k)) as of 24 Oct 2026. One FDA recall is linked to it.

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 Withdrawn in European Union.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

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212100

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number93532780KOSMOSWH Basic UDI-DI 09353278000588UDI-DIDate29 Oct 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number09353278000588 UDI-DI Date27 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212100 Date6 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 93532780KOSMOSWH registered 29 Oct 2021 Withdrawn
  • FDA 510(k) K212100 decided 6 Aug 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 09353278000588 listed 27 Oct 2021 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2325-2024 FDA Class II initiated 9 May 2024

    Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

Timeline

5 dated events

  1. Cleared FDA 510(k) K193518
  2. Cleared FDA 510(k) K212100
  3. Listed FDA GUDID 09353278000588
  4. Registered EUDAMED 93532780KOSMOSWH
  5. Recall initiated FDA recalls Z-2325-2024

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Kosmos Software [Android] EUDAMED
Kosmos OTS GUDID
Generic name
Ultrasound imaging system application software
Device name
Kosmos
Model / reference
P006576
Primary DI / UDI-DI
09353278000588
Basic UDI-DI
93532780KOSMOSWH
510(k) Number
FDA product code
IYO, IYN
EMDN code
Z11040106 Handheld ultrasound scanners
GMDN term
Ultrasound imaging system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 892.1550
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
US-MF-000004161
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under HANDHELD ULTRASOUND SCANNERS.

Other devices from EchoNous

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Properties

  • Prescription use
Other properties (24, all answered No)