510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K813032Substantially Equivalent

Zikon 100 Digital X-Ray System

Kontron Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813032 is the FDA 510(k) clearance record for ZIKON 100 DIGITAL X-RAY SYSTEM, a class II device, cleared for Kontron Instruments, Inc. on under FDA product code JAB (System, X-Ray, Fluoroscopic, Non-Image-Intensified). FDA records list 58 510(k) clearances for Kontron Instruments, Inc., from to . As of , FDA records show no recalls naming K813032.

Clearance record

Decision date
Received
(27 days to decision)
Product code
JAB System, X-Ray, Fluoroscopic, Non-Image-Intensified
Regulation
21 CFR 892.1660
Device class
Class II
Review panel
Radiology
Applicant
Kontron Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JAB

Trailing 12 months

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

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