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Lsn 1

by Imaging Biometrics, LLC

Lsn 1 is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Imaging Biometrics, LLC, cleared under FDA 510(k) K201092 on 29 Oct 2020 and listed in FDA GUDID since 14 Apr 2026 (UDI-DI B319LSN1), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K201092

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB319LSN1 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201092 Date29 Oct 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201092 decided 29 Oct 2020 Active
  • FDA GUDID UDI-DI B319LSN1 listed 14 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201092
  2. Listed FDA GUDID B319LSN1

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lsn
Generic name
Radiology DICOM image processing application software
Model / reference
1
Primary DI / UDI-DI
B319LSN1
510(k) Number
FDA product code
JAK
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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Properties

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