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Promap Lite

by Koelis

Ref KSOF-2602-LiModel PROMAP LITE

Promap Lite (KSOF-2602-Li) is an image segmentation application software (EU MDD Class I; FDA Class II) made by Koelis, registered in EUDAMED on 11 Feb 2026 (Basic UDI-DI B-03665134000714), cleared under FDA 510(k) K170521 on 30 May 2017 and listed in FDA GUDID since 21 Jul 2022 (UDI-DI 03665134000714), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170521

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03665134000714 Basic UDI-DI 03665134000714UDI-DIDate11 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03665134000714 UDI-DI Date21 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK170521 Date30 May 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-03665134000714 registered 11 Feb 2026 Active
  • FDA 510(k) K170521 decided 30 May 2017 Active
  • FDA GUDID UDI-DI 03665134000714 listed 21 Jul 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170521
  2. Listed FDA GUDID 03665134000714
  3. Registered EUDAMED B-03665134000714

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  • Withdrawn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
Promap Lite EUDAMED
Promap Lite – 3D Prostate Suite GUDID
Generic name
Image segmentation application software
Model / Ref / Catalog
PROMAP LITE, KSOF-2602-Li, KSOF-2602
Primary DI / UDI-DI
03665134000714
Basic UDI-DI
B-03665134000714
510(k) Number
FDA product code
LLZ, ITX, IYO, IYN
EMDN code
Z11040192 Ultrasound scanners - medical device software
GMDN term
Image segmentation application software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050, 892.1570, 892.1560, 892.1550
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
PROMAP LITE
KSOF-2602-Li
GUDID
KSOF-2602
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
FR-MF-000000830

Similar devices in this category

Other devices filed under ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE.

Other devices from Koelis

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Properties

  • Measuring function
  • Prescription use
Other properties (21, all answered No)