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StoneChecker 1.1

by Imaging Biometrics, LLC

StoneChecker 1.1 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Imaging Biometrics, LLC, cleared under FDA 510(k) K191530 on 26 Sep 2019 and listed in FDA GUDID since 14 Apr 2026 (UDI-DI B319SC11), 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) K191530

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 NumberB319SC11 UDI-DI Date14 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK191530 Date26 Sep 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191530 decided 26 Sep 2019 Active
  • FDA GUDID UDI-DI B319SC11 listed 14 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191530
  2. Listed FDA GUDID B319SC11

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
StoneChecker
Generic name
Radiology DICOM image processing application software
Model / reference
1.1
Primary DI / UDI-DI
B319SC11
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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Properties

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