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LSN

by Imaging Biometrics, LLC

510(k) K201092Ref LSN

Active European Union and United States

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) K201092↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B319LSN10JD Basic UDI-DI D-B319LSN10JDUDI-DIDate27 Feb 2023RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK201092 Date29 Oct 2020ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B319LSN10JD registered 27 Feb 2023 Active
  • FDA 510(k) K201092 decided 29 Oct 2020 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K201092
  2. Registered EUDAMED B-B319LSN10JD

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  • Withdrawn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 · 510(k)

Model / reference
LSN
Primary DI / UDI-DI
D-B319LSN10JD
Basic UDI-DI
B-B319LSN10JD
510(k) Number
FDA product code
JAK
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
Device class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.1750
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class I
510(k)
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LSN is a Medical Image Processing Device (FDA Product Code JAK) designed for the analysis and quantification of radiological images, specifically for brain tumor characterization. It processes imaging data to provide objective measurements and metrics that assist in diagnostic and treatment planning workflows.

This device is supplied as software and operates within a clinical radiology setting, requiring integration with existing imaging systems for data input. It is intended for single-use per imaging session, with no sterility requirements, and is classified as non-MRI conditional. Authorisations include FDA 510(k) clearance under the Medical Devices Directive (MDD) and are applicable in the United States. No third-party reprocessing is permitted.

Devices cleared under K201092

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K201092
UDI-DISize and differences
LSN 1
Imaging Biometrics, LLC
1B319LSN1 —On the market

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Properties

Other properties (12, all answered No)