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DMI Console

by Dimensional Medicine, Inc. 510(k)

Active United States

510(k) K844317

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844317 Date26 Feb 1985ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 21 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 DMI Console is a Class II X-ray system used in radiology. It is a medical device designed for imaging purposes within radiology settings.

The device received FDA 510(k) clearance under K-number K844317 on February 26, 1985, and is substantially equivalent to a predicate device. It is manufactured by Dimensional Medicine, Inc. and classified under product code LLZ.

Other devices from Dimensional Medicine, Inc.