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Kosmos OTS Android Linear P007213

by EchoNous

Kosmos OTS Android Linear P007213 is a Class II device made by EchoNous, cleared under FDA 510(k) K212100 on 6 Aug 2021 (1 earlier submission), registered in EUDAMED and listed in FDA GUDID since 6 Sep 2022 (UDI-DI 09353278000687), active as of 23 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09353278000687 UDI-DI Date6 Sep 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK212100 Date6 Aug 2021DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K212100 decided 6 Aug 2021 Active· +1 more in the status table
  • EUDAMED Active
  • FDA GUDID UDI-DI 09353278000687 listed 6 Sep 2022 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

4 dated events

  1. Cleared FDA 510(k) K193518
  2. Cleared FDA 510(k) K212100
  3. Listed FDA GUDID 09353278000687
  4. 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  • Withdrawn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 Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Kosmos OTS Android Linear
Generic name
Ultrasound imaging system application software
Model / reference
P007213
Primary DI / UDI-DI
09353278000687
510(k) Number
FDA product code
IYO, IYN
GMDN term
Ultrasound imaging system application software
Device class
Class II
Regulation number
892.1560, 892.1550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ultrasound imaging system application software

Cleared under the same submission (K193518)

and 1 more cleared under K193518

Cleared under the same submission (K212100)

Similar devices in this category

Other devices filed under Ultrasound imaging system application software.

Other devices from EchoNous

See all devices from EchoNous →

Properties

  • Prescription use
Other properties (14, all answered No)