510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K925289Substantially Equivalent

Matrix Cr 2050, Pmi 3000

Kulzer GmbH, Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925289 is the FDA 510(k) clearance record for MATRIX CR 2050, PMI 3000, a class II device, cleared for Heraeus Kulzer, Inc. on under FDA product code LMC (Camera, Multi Format, Radiological). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K925289.

Clearance record

Decision date
Received
(169 days to decision)
Product code
LMC Camera, Multi Format, Radiological
Regulation
21 CFR 892.2040
Device class
Class II
Review panel
Radiology
Applicant
Heraeus Kulzer, Inc. 1 Ramland Rd., Orangeburg NY
510(k) summary
Summary
Third party review
No

Clearances, product code LMC

Trailing 12 months

FDA records hold no clearances under product code LMC in the trailing twelve months.

FDA records show no clearances under product code LMC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260