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Koios DS 3.x

by Koios Medical, Inc.

Ref KDS-3XXModel Koios DS 3.8

Koios DS 3.x is a device classified as Class IIb in the EU and Class II in the US made by Koios Medical, Inc., registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 086000254573XTF) with CE/MDR certificate 28620136087-01 valid until 9 Aug 2027, cleared under FDA 510(k) K253884 on 2 Jul 2026 (2 earlier submissions) and listed in FDA GUDID since 12 Jan 2022 (UDI-DI 00860002545714), active as of 24 Oct 2026.

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

CE MDR 510(k)

Valid until

9 Aug 2027

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

510(k) K253884

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number086000254573XTF Basic UDI-DI 00860002545714UDI-DIDate3 Sep 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK253884 Date2 Jul 2026DecidedStatusActive
United StatesGUDID listing GUDID Number00860002545714 UDI-DI Date12 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 086000254573XTF registered 3 Sep 2026 Active· +1 more in the status table
  • FDA 510(k) K253884 decided 2 Jul 2026 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00860002545714 listed 12 Jan 2022 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

7 dated events

  1. Cleared FDA 510(k) K212616
  2. Listed FDA GUDID 00860002545714
  3. Certificate issued EUDAMED 28620136087-01
  4. Cleared FDA 510(k) K242130
  5. Cleared FDA 510(k) K253884
  6. Registered EUDAMED 086000254573XTF
  7. Certificate expires EUDAMED 28620136087-01

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Koios DS
Generic name
Breast ultrasound clinical assessment support software
Model / reference
Koios DS 3.8 EUDAMED
KDS-3XX EUDAMED
3.x GUDID
Primary DI / UDI-DI
00860002545714
Basic UDI-DI
086000254573XTF
510(k) Number
FDA product code
POK, QIH
EMDN code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
GMDN term
Breast ultrasound clinical assessment support software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2060, 892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Koios DS 3.8
KDS-3XX
GUDID
3.x
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Koios Medical, Inc.

  • Koios DS (3.8)

    Class II

  • Koios Medical 2.x

    Class II

  • Koios DS

    Class II

  • Koios DS for Breast

    Class II

See all devices from Koios Medical, Inc. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)