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MEDSYNAPSE Zero Footprint Viewer

by Medsynaptic Private, Ltd.

510(k) K163158

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 NumberK163158 Date2 Dec 2016ClearedStatusActive

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  • Withdrawn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, 19 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 Medsynapse Zero Footprint Viewer is a zero-footprint picture archiving and communication system (PACS) viewer (Product Code LLZ) designed for remote access and display of medical images. It enables secure transmission, storage, retrieval, and viewing of digital imaging data without requiring local installation, leveraging web-based or mobile platforms for compatibility.

This device is supplied as a software-based solution, intended for use in radiology workflows to distribute images across hospital networks and external systems. It operates as a single-user, non-sterile application with no regulatory restrictions on MRI compatibility. The system requires internet connectivity and supports display resolutions optimized for Chrome or Safari browsers, with no physical hardware footprint beyond the end-user device. Its FDA 510(k) clearance (K163158) under the Radiology Advisory Committee confirms substantial equivalence to a predicate device.

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