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Briefcase-Triage

by Aidoc Medical Ltd.

Ref BC.TRG510(k) K261317

Active European Union and United States

CE MDR 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) K261317↗

+27 more

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK261317 Date14 May 2026IssuedStatusActive
European UnionCE/MDR EUDAMED Number7290018052BC.TRGSU Basic UDI-DI Date6 May 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K261317 decided 14 May 2026 Active· +27 more in the status table
  • EUDAMED Basic UDI-DI 7290018052BC.TRGSU registered 6 May 2025 Active

Timeline

29 dated events

  1. Cleared FDA 510(k) K241727
  2. Cleared FDA 510(k) K242837
  3. Cleared FDA 510(k) K243548
  4. Cleared FDA 510(k) K250248
  5. Registered EUDAMED 7290018052BC.TRGSU
  6. Cleared FDA 510(k) K251406
  7. Cleared FDA 510(k) K253265
  8. Cleared FDA 510(k) K252970
  9. Cleared FDA 510(k) K251195
  10. Cleared FDA 510(k) K261317

19 earlier events are in the sections above.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
BC.TRG
Primary DI / UDI-DI
07290018052310, 07290018052440
Basic UDI-DI
7290018052BC.TRGSU
Direct marketing DI
07290018052310
07290018052440
510(k) Number
FDA product code
QAS
EMDN code
Z11069092 Various digital bioimaging management instruments - medical device software
Device class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 892.2080
Special device type
Software
EU registration type
Standard device
EU market of registration
Belgium
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

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

Device class is stated on each registry's own scale: Class IIa 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.

Manufacturer details

EUDAMED SRN
IL-MF-000030988
FDA applicant
Aidoc Medical , Ltd.
Authorised representative
Obelis s.a. BE-AR-000000106

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.

Briefcase Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT chest, abdomen, or other images. It is designed to assist with triage and prioritization of medical images. The device contains the software platform and image analysis algorithms to help radiologists prioritize medical images that need immediate attention. It is a Class IIa device with a nomenclature code of Z11069092.

Briefcase Triage is a single-use, non-implantable, and non-sterile device. It is not intended for administering medicine, and it does not contain animal tissues or latex. The device has been authorized with FDA 510K and MDR approvals. It is supplied with a unique reference code BC.TRG and a basic UDI of 7290018052BC.TRGSU.

Similar devices in this category

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

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Properties

Other properties (14, all answered No)