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510(k) K123254

ULTRASOUND SCANNER FLEX FOCUS by B-K Medical Aps — Product Code IYN

K123254 is an FDA 510(k) premarket notification submitted by B-K Medical Aps for the device "ULTRASOUND SCANNER FLEX FOCUS". The FDA issued a decision of Substantially Equivalent on Feb 13, 2013. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. B-K Medical Aps has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 13, 2013
Date Received
Oct 18, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Device Class
Class II
Regulation Number
892.1550
Review Panel
RA
Submission Type
510(k)

Other clearances by B-K Medical Aps

  • K140428 — ULTRASOUND SCANNER SYSTEM BK2300 (May 30, 2014)
  • K132346 — ULTRASOUND SCANNER PRO FOCUS 2202 (Jan 10, 2014)
  • K132335 — ULTRASOUND SCANNER FLEX FOCUS 1202 (Jan 10, 2014)
  • K132677 — ULTRASOUND SCANNER FLEX FOCUS 1202 (Jan 7, 2014)
  • K132685 — ULTRASOUND SCANNER PRO FOCUS 2202 (Jan 6, 2014)
  • K100919 — PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 (Dec 16, 2011)
  • K083667 — NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336… (Feb 2, 2009)
  • K081323 — BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 (Jul 22, 2008)
  • K081154 — ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 (May 23, 2008)
  • K070077 — ULTRASOUND SCANNER PROFOCUS, MODEL 2202 (Mar 5, 2007)

Other clearances for product code IYN

  • K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus (Sep 2, 2026)
  • K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo… (Aug 24, 2026)
  • K261668 — Venue Go (Aug 7, 2026)
  • K262311 — Alturion Series Diagnostic Ultrasound System (Aug 4, 2026)
  • K261288 — Handheld Ultrasound Scanner (Jul 30, 2026)
  • K261835 — LOGIQ Focus (Jul 30, 2026)
  • K261412 — V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound… (Jul 28, 2026)
  • K261211 — Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series… (Jul 27, 2026)
  • K261081 — Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (Jul 23, 2026)
  • K261272 — ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/… (Jul 23, 2026)

FDA data resources