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Dg Pacs

by Dicom Grid, Inc. 510(k)

Active United States

510(k) K152977

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152977 Date25 Jan 2016ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1045-2017 FDA Class II initiated 16 Dec 2016

    A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.

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