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Medsynapse Ris Pacs & Medsynapse VNA

by Medsynaptic Private, Ltd.

510(k) K192508

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 NumberK192508 Date22 Nov 2019ClearedStatusActive

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  • Withdrawn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, 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 Medsynapse RIS-PACS & Medsynapse VNA is a Radiology Information System (RIS) and Picture Archiving and Communication System (PACS) integrated with a Vendor-Neutral Archive (VNA). This enterprise imaging platform centralizes patient imaging studies, radiological reports, and unstructured clinical data, enabling seamless management of radiology workflows. It supports vendor-neutral integration, allowing compatibility with multiple PACS systems and proprietary imaging requirements. The system enhances operational efficiency by streamlining patient information, study tracking, and report generation within radiology departments.

The Medsynapse RIS-PACS & Medsynapse VNA is designed for use in radiology departments and healthcare facilities requiring scalable image and data management. It operates as a centralized repository for medical images, studies, and clinical content, ensuring interoperability with existing systems. The device is single-use or reusable (as determined by institutional policy) and is not MRI-safe unless explicitly configured for non-magnetic environments. Supplied as a software platform, it requires compatible hardware infrastructure for deployment. Authorized under FDA 510(k) clearance (K192508), it adheres to regulatory standards for radiology information systems and imaging archives.

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