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: The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and homes. To provide the basis for the implementation of clinical catheterization, evaluate the residual volume after micturition, and make auxiliary diagnosis for the diseases of bladder and renal function. The instrument is also suitable for people with lower body disability and loss of self urination function to master the timing of urination. FDA UDI
Model / Reference: M4 FDA UDI
Description: The instrument is suitable for the measurement of bladder volume in hospitals, nursing homes and homes. To provide the basis for the implementation of clinical catheterization, evaluate the residual volume after micturition, and make auxiliary diagnosis for the diseases of bladder and renal function. The instrument is also suitable for people with lower body disability and loss of self urination function to master the timing of urination. FDA UDI

Identifiers

Primary DI / UDI-DI: 06975124100537 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 90032db7-f502-4eb5-90b9-a17e25dad7e1 34 fields · synced May 30, 2026