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510(k) K896150

IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC by Teknar, Inc. — Product Code IYO

K896150 is an FDA 510(k) premarket notification submitted by Teknar, Inc. for the device "IMAGE 2000 SYSTEM, IMAGING, ULTRA-SONIC". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Teknar, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1990
Date Received
October 23, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Teknar, Inc.

  • K903666 — OPHTHASONIC A/P III (November 19, 1990)
  • K896038 — B-SCAN 10 MHZ PROBE (April 23, 1990)
  • K891777 — PRO-CUT BIOPSY NEEDLE (May 4, 1989)
  • K883965 — PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR (October 5, 1988)
  • K881850 — TEKNAR PERCU-SCAN (August 29, 1988)
  • K881605 — BIOPSY GUIDE (June 21, 1988)
  • K880659 — TEKNAR PROSCAN ACCESSORY PROBE (April 14, 1988)
  • K871536 — OPHTHASONIC A-SCAN/ B-SCAN (August 26, 1987)
  • K864807 — TEKNAR PROSCAN(TM) (July 10, 1987)
  • K860757 — OPHTHASONIC A-SCAN (December 18, 1986)

Other clearances for product code IYO

  • K260190 — ARTHUR (June 18, 2026)
  • K252237 — EdgeFlow UW20 (April 17, 2026)
  • K254021 — Accuro XV (April 9, 2026)
  • K253898 — QT Scanner 2000 Model A (March 4, 2026)
  • K253714 — IntraSight Plus (February 24, 2026)
  • K253221 — Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) (February 6, 2026)
  • K250331 — Astrasono A3Pro Bladder Scanner (A3Pro) (September 30, 2025)
  • K250381 — Deepsight NeedleVue LC1 Ultrasound System (August 1, 2025)
  • K243227 — B-Scan (July 11, 2025)
  • K251728 — Velacur One (LI-1100) (June 26, 2025)

FDA data resources