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EV Insite System

by Psp Corporation

510(k) K152716

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 NumberK152716 Date24 Mar 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  • Withdrawn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, 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.

The EV Insite System is a medical device that receives medical images and data from various imaging sources. It is designed to store, communicate, process, and display images and data within the system or across computer networks.

Manufactured by Psp Corporation, the device received FDA 510(k) clearance on March 24, 2016, under the traditional pathway with K-number K152716. It is classified under product code LLZ and was reviewed by the Radiology advisory committee.

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 EV Insite System used for?

    The EV Insite System is designed to receive medical images and data from various imaging sources, then store, communicate, process, and display those images and data either within the system or across computer networks, supporting clinical workflows in radiology and imaging departments.

  • Who manufactures the EV Insite System and when was it cleared?

    The EV Insite System is manufactured by Psp Corporation and received FDA 510(k) clearance on March 24, 2016, under the traditional pathway with K-number K152716, confirming it is substantially equivalent to a legally marketed predicate device.

  • What regulatory classification and review pathway applies to the EV Insite System?

    The device is classified under product code LLZ and was reviewed by the Radiology advisory committee as part of its traditional 510(k) submission, which determined it to be substantially equivalent (SESE) to a predicate device.