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Bladder Scanner M5

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K213488

by Suzhou Peaksonic Medical Technology Co., Ltd.

Identifiers

510(k) Number
K213488 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bladder Scanner M5 is a portable ultrasound device designed for non-invasive measurement of bladder volume and wall thickness. It employs ultrasound technology to provide accurate assessments of bladder dimensions, aiding clinical evaluations in patient care settings.

This device is intended for use in hospital, long-term care, and rehabilitation environments. Supplied as a reusable medical instrument, it requires appropriate sterilization procedures before each use. The Bladder Scanner M5 holds FDA 510(k) clearance under the Radiology advisory committee and is compliant with MDR regulations. Its design includes dual-screen display and bladder wall thickness measurement capabilities.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PEAKSONIC, PeakSonic Bladder Scanner M5 - PeakSonic Medical - PDF Catalogs ..., PDF Bladder Scanner Model:M5 User Manual - FCC ID Search

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Suzhou Peaksonic Medical Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K213488 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026