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Vu-Path Ultrasound System

by Crystalline Medical 510(k)

Active United States

510(k) K203657

Overview

The Vu-Path Ultrasound System is a Class II ultrasound imaging system manufactured by Crystalline Medical. It is a pulsed Doppler ultrasonic system designed for medical imaging applications. The device is intended for use in central vascular access procedures.

The Vu-Path Ultrasound System is supplied as a complete imaging system and is not specified as single-use or reusable. It has received FDA 510(k) clearance under K-number K203657 in 2021, classified under product code IYN. The device is intended for use in radiology settings.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK203657 Date25 Jun 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IYN
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Vu-Path Ultrasound System used for?

    The Vu-Path Ultrasound System is designed for medical imaging applications, specifically for use in central vascular access procedures in radiology settings. It provides pulsed Doppler ultrasonic imaging to assist clinicians during these procedures.

  • Is the Vu-Path Ultrasound System single-use or reusable?

    The Vu-Path Ultrasound System is supplied as a complete imaging system and is not specified as either single-use or reusable in the device information. This suggests it may be designed for multiple uses following appropriate cleaning and sterilization protocols.

  • What regulatory approvals does the Vu-Path Ultrasound System have?

    The Vu-Path Ultrasound System has received FDA 510(k) clearance under K-number K203657 in 2021. It is classified as a Class II device under product code IYN and was determined to be substantially equivalent to predicate devices.

  • What components are included with the Vu-Path Ultrasound System?

    The Vu-Path Ultrasound System is supplied as a complete imaging system, though specific components aren't detailed in the provided information. The system includes all necessary elements for pulsed Doppler ultrasonic imaging in central vascular access procedures.