Caresono

FDA UDI

Class II (US FDA UDI)

by Caresono Technology Co., Ltd.

Identity

Trade Name: Caresono FDA UDI
Generic Name: Bladder volume ultrasound imaging system FDA UDI
Device Name: Caresono HD5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes. FDA UDI
Model / Reference: HD5 FDA UDI
Description: Caresono HD5 is a 3D ultrasound bladder volume instrument used to measure bladder volume and bladder wall thickness noninvasively. It is widely used in hospitals, elderly care facilities and rehabilitation institutes. FDA UDI

Identifiers

Primary DI / UDI-DI: 16971003430013 FDA UDI
510(k) Number: K131227 FDA UDI
FDA Product Code: IYO FDA UDI
ITX FDA UDI
GMDN Term: Bladder volume ultrasound imaging system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
892.1570 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

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bladder volume ultrasound imaging system

Caresono by Caresono 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
Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
BBS Revolution™ — Dbmedx, Inc. · Class II
AVANTSONIC — Avantsonic Technology Co., Ltd. · Class II
Bladder Scanner — Suzhou PeakSonic Medical Technology Co., LTD. · Class II
ScanPoint® — Verathon Inc. · Class II
BladderScan® — Verathon Inc. · Class II

Cleared under the same submission

K131227 also covers:

Caresono — Caresono 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: Caresono Technology Co., Ltd.

Sources (1)

FDA UDI bfe110fe-c81a-4f54-a0ed-18ac48d9cc08 34 fields · synced May 31, 2026