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510(k) K813032

ZIKON 100 DIGITAL X-RAY SYSTEM by Kontron Instruments, Inc. — Product Code JAB

K813032 is an FDA 510(k) premarket notification submitted by Kontron Instruments, Inc. for the device "ZIKON 100 DIGITAL X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 24, 1981. The device falls under product code JAB (System, X-Ray, Fluoroscopic, Non-Image-Intensified), a Class II device regulated under 21 CFR 892.1660. Kontron Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1981
Date Received
October 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Non-Image-Intensified
Device Class
Class II
Regulation Number
892.1660
Review Panel
RA
Submission Type

Other clearances by Kontron Instruments, Inc.

  • K971038 — KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE (September 24, 1997)
  • K932268 — MODIFICATIONS TO INTRA-AORTIC BALLOONS (December 15, 1993)
  • K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS (September 27, 1993)
  • K923603 — INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION (March 8, 1993)
  • K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II (June 19, 1991)
  • K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) (January 15, 1991)
  • K896437 — KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM (December 3, 1990)
  • K892222 — 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON (September 14, 1990)
  • K882955 — SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (January 26, 1990)
  • K896386 — MINIMON 7133B PATIENT MONITOR (December 13, 1989)

Other clearances for product code JAB

  • K970782 — IMAGING JET SYSTEM (November 13, 1997)

FDA data resources