510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K934386Substantially Equivalent

Impax 5000

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

K934386 is the FDA 510(k) clearance record for IMPAX 5000, a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code LMD (System, Digital Image Communications, Radiological). FDA's definition for product code LMD reads: "A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, interfaces, and a communications protocol. It may provide simple...". FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K934386.

Clearance record

Decision date
Received
(119 days to decision)
Product code
LMD System, Digital Image Communications, Radiological
Regulation
21 CFR 892.2020
Device class
Class I
Review panel
Radiology
Applicant
Heraeus Kulzer, Inc. 1 Ramland Rd., Orangeburg NY
510(k) summary
Statement
Third party review
No

Clearances, product code LMD

Trailing 12 months

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

FDA records show no clearances under product code LMD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LMD, 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