ULTRASOUND SCANNER SYSTEM BK2300— 510(k) K140428

Clearance details

Applicant

B-K Medical Aps

Product code

Code IYO

Device class

Class 2

Regulation

21 CFR 892.1560

Advisory panel

Radiology

Date received

2014-02-19

Decision date

2014-05-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Herlev, DK

• K253452 — Accuro 3S2026-07-24
• K260190 — ARTHUR2026-06-18
• K252237 — EdgeFlow UW202026-04-17
• K254021 — Accuro XV2026-04-09
• K253898 — QT Scanner 2000 Model A2026-03-04

• K132335 — ULTRASOUND SCANNER FLEX FOCUS 12022014-01-10
• K132346 — ULTRASOUND SCANNER PRO FOCUS 22022014-01-10
• K132677 — ULTRASOUND SCANNER FLEX FOCUS 12022014-01-07
• K132685 — ULTRASOUND SCANNER PRO FOCUS 22022014-01-06
• K123254 — ULTRASOUND SCANNER FLEX FOCUS2013-02-13

Malfunction

3,339

Total

3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2325-2016 — BK Medical ApS Ultrasound System Scanner bk2300 - Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYNClass II·Terminated·B-K Medical A/S·20160628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140428.