Bladder Scanner

FDA UDI

Class II (US FDA UDI)

by Suzhou PeakSonic Medical Technology Co., LTD.

Identity

Trade Name: Bladder Scanner FDA UDI
Generic Name: Bladder volume ultrasound imaging system FDA UDI
Device Name: PeakSonic M3 is a handheld portable bladder volume instrument, which can be applied in the department of Surgery, Emergency, ICU, Obstetric, Gynecology, radiotherapy and nursing home. It can provide the basis for clinical catheterization, evaluate the post-void residual after patient urination, and make auxiliary diagnosis on the bladder and kidney diseases. The system is also suitable for patients of lower body disability or loss of auto-urination function, to confirm the proper timing of urination. FDA UDI
Model / Reference: M3 FDA UDI
Description: PeakSonic M3 is a handheld portable bladder volume instrument, which can be applied in the department of Surgery, Emergency, ICU, Obstetric, Gynecology, radiotherapy and nursing home. It can provide the basis for clinical catheterization, evaluate the post-void residual after patient urination, and make auxiliary diagnosis on the bladder and kidney diseases. The system is also suitable for patients of lower body disability or loss of auto-urination function, to confirm the proper timing of urination. FDA UDI

Identifiers

Primary DI / UDI-DI: 06975124100421 FDA UDI
510(k) Number: K201316 FDA UDI
FDA Product Code: ITX FDA UDI
IYO FDA UDI
GMDN Term: Bladder volume ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1570 FDA UDI
892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bladder volume ultrasound imaging system

Bladder Scanner by Suzhou PeakSonic Medical Technology Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bladder volume ultrasound imaging system.

BladderScan® — Verathon Inc. · Class II
BladderScan® — Verathon Inc. · Class II
BBS Revolution™ — Dbmedx, Inc. · Class II
Caresono — Caresono Technology Co., Ltd. · Class II
AVANTSONIC — Avantsonic Technology Co., Ltd. · Class II
ScanPoint® — Verathon Inc. · Class II
Caresono — Caresono Technology Co., Ltd. · Class II
BladderScan® — Verathon Inc. · Class II

Cleared under the same submission

K201316 also covers:

Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Suzhou PeakSonic Medical Technology Co., LTD.

Sources (1)

FDA UDI f3095cda-f0a3-4326-b431-3a3500dc59e3 34 fields · synced May 30, 2026