FDA 510(k)

ULTRASOUND SCANNER FLEX FOCUS

K-Number: K123254 · 2013-02-13

Decision Date2013-02-13

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER FLEX FOCUS is the device name listed in this FDA 510(k) record. The listed applicant is B-K Medical Aps. It received FDA 510(k) clearance on 2013-02-13 under 510(k) number K123254. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASOUND SCANNER FLEX FOCUS?

ULTRASOUND SCANNER FLEX FOCUS is a medical device that received FDA 510(k) clearance on 2013-02-13. The listed applicant is B-K Medical Aps. The 510(k) number is K123254.

When did ULTRASOUND SCANNER FLEX FOCUS receive FDA 510(k) clearance?

ULTRASOUND SCANNER FLEX FOCUS received FDA 510(k) clearance on 2013-02-13, under 510(k) number K123254.

Who is the listed applicant for ULTRASOUND SCANNER FLEX FOCUS?

The FDA 510(k) record lists B-K Medical Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER FLEX FOCUS?

The FDA product code for ULTRASOUND SCANNER FLEX FOCUS is IYN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing B-K Medical Aps as applicant

K100919PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202 K083667NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 K081323BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 K081154ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 K070077ULTRASOUND SCANNER PROFOCUS, MODEL 2202

Related Devices (Code: IYN)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.