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AngioCloud Service

by Angiocloud, LLC

510(k) K211713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK211713 Date28 Apr 2022ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AngioCloud Service is a medical image management and processing system. It enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery.

The device is supplied by Angiocloud, LLC and received FDA 510(k) clearance under K211713 on April 28, 2022. It is classified as a Class II device under regulation 21 CFR 892.2050 with product code LLZ.

Questions

AI-generated answers, 22 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 is the AngioCloud Service used for?

    The AngioCloud Service enables visualization and measurement of cerebral blood vessels to support preoperative planning and sizing for neurovascular interventions and surgery, as stated in its device description.

  • How is the AngioCloud Service supplied and is it reusable?

    The AngioCloud Service is supplied by Angiocloud, LLC as a medical image management and processing system; the provided data does not specify whether it is single-use or reusable, so no conclusion about reusability can be drawn from the facts given.

  • What regulatory clearance does the AngioCloud Service have?

    The AngioCloud Service received FDA 510(k) clearance under K211713 on April 28, 2022, and is classified as a Class II device under 21 CFR 892.2050 with product code LLZ.