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Neuro.Al Algorithm

by Terarecon Inc.

510(k) K200750

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) K200750↗

FDA record

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)SESE 510(k) Substantially Equivalent · Special NumberK200750 Date6 Nov 2020ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200750 decided 6 Nov 2020 Active
  • EUDAMED Active· +1 more in the status table

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  • Withdrawn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
FDA applicant
Terarecon,Inc.
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

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 Neuro.Al Algorithm is a radiology software algorithm designed for automated analysis of neuroimaging data, specifically to assist in the detection and quantification of abnormalities in brain scans. It leverages advanced computational techniques to enhance diagnostic workflows by providing structured, interpretable outputs from medical imaging studies, such as MRI or CT scans.

This algorithm is supplied as a software-based solution for use in radiology departments, hospitals, or clinical research settings. It operates on standard imaging platforms and does not require physical sterilization or single-use disposal; however, its regulatory compliance includes FDA 510(k) clearance under Special Review (K200750) and adherence to the EU Medical Device Directive (MDD) and Medical Device Regulation (MDR). No specific MRI safety classification or sterility requirements are noted in the data, and its use is governed by the manufacturer’s software licensing terms.

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