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StoneChecker

by Imaging Biometrics, LLC

Ref StoneChecker

StoneChecker is a medical device (EU MDD Class I) made by Imaging Biometrics, LLC, registered in EUDAMED on 27 Feb 2023 (Basic UDI-DI B-B319STONECHECKER11ED) and cleared under FDA 510(k) K191530 on 26 Sep 2019, active as of 25 Oct 2026.

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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191530↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-B319STONECHECKER11ED Basic UDI-DI D-B319STONECHECKER11EDUDI-DIDate27 Feb 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK191530 Date26 Sep 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-B319STONECHECKER11ED registered 27 Feb 2023 Active
  • FDA 510(k) K191530 decided 26 Sep 2019 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K191530
  2. Registered EUDAMED B-B319STONECHECKER11ED

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
StoneChecker
Primary DI / UDI-DI
D-B319STONECHECKER11ED
Basic UDI-DI
B-B319STONECHECKER11ED
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
Device class
Class I
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000033700
Authorised representative
Casus Consulting Limited IE-AR-000023507

Similar devices in this category

Other devices filed under VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Imaging Biometrics, LLC

  • IB FTB Express 2.0

    Class II

  • QSMetric 1

    Class II

  • Lsn 1

    Class II

  • StoneChecker 1.1

    Class II

See all devices from Imaging Biometrics, LLC →

Properties

Other properties (12, all answered No)