ADAS3D

by ADAS3D Medical, S.L.

Ref ADAS 3D, ADAS 3D ver. 2.9510(k) K240791

Active European Union and United States

CE MDR 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) K240791↗

+3 more

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k) 510(k)	NumberK240791	Date9 Sep 2024Issued	StatusActive
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Special	NumberK230803	Date23 May 2023Cleared	StatusActive
European Union	CE/MDR EUDAMED	NumberB-08437021722017 Basic UDI-DI 08437021722017UDI-DI	Date5 Oct 2021Registered	StatusActive
European Union	CE/MDD EUDAMED	NumberB-08437021722017 Basic UDI-DI 08437021722017UDI-DI	Date5 Oct 2021Registered	StatusActive
United States	FDA 510(k) 510(k)	NumberK212421	Date3 Sep 2021Issued	StatusActive
United States	FDA 510(k) 510(k)	NumberK210850	Date5 Apr 2021Issued	StatusActive

Official records

EUDAMED public site Basic UDI-DI B-08437021722017 — open Devices and search for it
FDA 510(k) database 510(k) number K240791
FDA 510(k) database 510(k) number K230803
FDA 510(k) database 510(k) number K212421
FDA 510(k) database 510(k) number K210850

Across registries

2 registries list this device

FDA 510(k) K240791 decided 9 Sep 2024 Active· +3 more in the status table
EUDAMED Basic UDI-DI B-08437021722017 registered 5 Oct 2021 Active· +1 more in the status table

Timeline

5 dated events

5 Apr 2021 Cleared FDA 510(k) K210850
3 Sep 2021 Cleared FDA 510(k) K212421
5 Oct 2021 Registered EUDAMED B-08437021722017
23 May 2023 Cleared FDA 510(k) K230803
9 Sep 2024 Cleared FDA 510(k) K240791

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR, CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device name: ADAS3D
Adas 3D
Model / reference: ADAS 3D, ADAS 3D ver. 2.9

Primary DI / UDI-DI: 08437021722017
Basic UDI-DI: B-08437021722017, 8437021722ADAS3DWX
EMDN code: Z11039082, Z12059092

Device class: Class IIa
Special device type: Software
EU registration type: Legacy device (under a directive)
Standard device
EU market of registration: Spain

Manufacturer details

EUDAMED SRN: ES-MF-000000391
FDA applicant: Adas3D Medical S.L.

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 ADAS3D is a Class IIa active medical device, classified under nomenclature code Z11039082. It is designed as a diagnostic imaging system, specifically for three-dimensional (3D) imaging of anatomical structures, enabling detailed visualization for clinical assessment.

This device is non-sterile, non-reusable, and non-implantable, intended for single-use applications. Supplied with a unique Basic UDI (B-08437021722017), it operates in clinical settings such as radiology departments and is authorized under FDA 510K, MDD, and MDR regulations. Storage and handling must comply with manufacturer guidelines to ensure proper functionality and safety.

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Properties

Other properties (14, all answered No)