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Static Vessel Analyzer

by Imedos GmbH

510(k) K082196

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 NumberK082196 Date16 Jun 2009ClearedStatusActive

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  • Withdrawn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
HKI
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Static Vessel Analyzer is an ophthalmic camera designed for static vessel analysis, enabling non-invasive, contact-free assessment of retinal vessel morphology. It captures and analyzes retinal images to derive vascular parameters, which serve as biomarkers for evaluating vascular health and microcirculation. These parameters are used as risk factors or prognostic indicators for vascular diseases and cardiovascular events.

This device is supplied as an ophthalmic camera with AC power and is intended for use in clinical or research settings. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The analyzer is reusable and requires proper storage and handling as specified by the manufacturer. No MRI safety information is provided, and its regulatory status is confirmed by the FDA clearance under the advisory committee for ophthalmic devices.

Questions

AI-generated answers, 1 Oct 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 Static Vessel Analyzer used for?

    The Static Vessel Analyzer is designed for non-invasive, contact-free assessment of retinal vessel morphology. It captures and analyzes retinal images to derive vascular parameters, which serve as biomarkers for evaluating vascular health and microcirculation. These parameters help identify risk factors or prognostic indicators for vascular diseases and cardiovascular events, making it useful in both clinical and research settings.

  • How is the Static Vessel Analyzer supplied and powered?

    The Static Vessel Analyzer is supplied as an ophthalmic camera and requires AC power for operation. It is intended for use in clinical or research environments where stable electrical connectivity is available.

  • Is the Static Vessel Analyzer reusable or single-use?

    The Static Vessel Analyzer is classified as a reusable device. Proper storage and handling, as specified by the manufacturer, are required to maintain its functionality and ensure patient safety.

  • Does the Static Vessel Analyzer have any MRI safety information?

    No MRI safety information is provided for the Static Vessel Analyzer. Users should consult the manufacturer’s guidelines to ensure safe handling and storage, particularly in environments where MRI procedures are conducted.

  • What regulatory status does the Static Vessel Analyzer hold?

    The Static Vessel Analyzer has received FDA 510(k) clearance and is classified as a Class II medical device under FDA regulations. It was reviewed by the Ophthalmic Devices Advisory Committee and determined to be substantially equivalent to a predicate device.