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ADAS 3D

by Galgo Medical S.L

510(k) K191125

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

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) K191125↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK191125 Date15 Jan 2020ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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 ADAS 3D is a 3D imaging system for radiologic applications, designed to provide detailed volumetric reconstructions of anatomical structures. It falls under the category of radiologic diagnostic devices, enabling precise visualization for diagnostic and treatment planning purposes in medical imaging.

This device is supplied as a reusable medical instrument, intended for use in radiology departments or imaging centers. It operates under FDA 510(k) clearance (K191125) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The system requires appropriate training for operation and must be maintained according to manufacturer guidelines to ensure accurate imaging performance.

Questions

AI-generated answers, 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.

  • What types of medical facilities or departments would benefit most from using the ADAS 3D imaging system?

    The ADAS 3D is designed specifically for radiology departments or imaging centers where detailed volumetric reconstructions of anatomical structures are required. Its advanced 3D imaging capabilities make it particularly useful for diagnostic purposes and treatment planning, ensuring precise visualization for clinicians working in these specialized environments.

  • Is the ADAS 3D system single-use or reusable, and what maintenance is required to keep it functioning properly?

    The ADAS 3D is a reusable medical instrument, meaning it is built for repeated use in clinical settings. To maintain accurate imaging performance, it must be cleaned, serviced, and maintained according to the manufacturer’s guidelines. Proper upkeep is essential, as the system requires specialized training for operation and relies on consistent technical integrity for reliable diagnostic results.

  • How does the ADAS 3D differ from traditional 2D imaging systems in terms of its intended use?

    Unlike traditional 2D imaging systems, the ADAS 3D provides volumetric reconstructions of anatomical structures, offering a three-dimensional perspective rather than flat, two-dimensional slices. This advanced capability enhances diagnostic precision and supports more accurate treatment planning in radiology, making it ideal for complex cases where depth and spatial relationships are critical.

  • What regulatory approvals does the ADAS 3D hold, and how does this affect its availability in different markets?

    The ADAS 3D holds FDA 510(k) clearance (K191125), indicating it is deemed substantially equivalent to a legally marketed device in the U.S. It also complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in Europe. These approvals ensure its legal use in markets where these regulations apply, though buyers should verify local compliance requirements before procurement.