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510(k) K023457

ULTRASOUND SCANNER, TYPE 1101 by B-K Medical A/S — Product Code IYO

K023457 is an FDA 510(k) premarket notification submitted by B-K Medical A/S for the device "ULTRASOUND SCANNER, TYPE 1101". The FDA issued a decision of Substantially Equivalent on November 1, 2002. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. B-K Medical A/S has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2002
Date Received
October 15, 2002
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 B-K Medical A/S

  • K043554 — ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 (January 14, 2005)
  • K043524 — ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 (January 13, 2005)
  • K024236 — ULTRASOUND SCANNER, TYPE 2400 (January 17, 2003)
  • K011417 — ULTRASOUND SCANNER, TYPE 2102 (June 8, 2001)
  • K003986 — ULTRASOUND SCANNER TYPE 2102 (April 3, 2001)
  • K003041 — ULTRASOUND SCANNER TYPE 2101 (February 7, 2001)

Other clearances for product code IYO

  • K253452 — Accuro 3S (July 24, 2026)
  • 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)

FDA data resources