Portable Image Processor

FDA UDIEUDAMED

Class II (US FDA UDI)

by Suzhou AcuVu Medical Technology Co., Ltd.

Identity

Trade Name: Portable Image Processor FDA UDI
Generic Name: Rigid video hysteroscope FDA UDI
Device Name: The HTx2000 Portable Image Processor is mainly used to process image signal captured from the disposable hysteroscope and present it on the screen or to an external display. It is also used as a central connection hub to external devices through various interfaces. FDA UDI
Model / Reference: HTx2000 FDA UDI
Description: The HTx2000 Portable Image Processor is mainly used to process image signal captured from the disposable hysteroscope and present it on the screen or to an external display. It is also used as a central connection hub to external devices through various interfaces. FDA UDI

Identifiers

Primary DI / UDI-DI: 06974880991366 FDA UDI
510(k) Number: K231260 FDA UDI
FDA Product Code: HIH FDA UDI
GMDN Term: Rigid video hysteroscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 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: Rigid video hysteroscope

Portable Image Processor by Suzhou AcuVu Medical Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Rigid video hysteroscope.

EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
Hysteroscope — Innoview GmbH · Class IIa
EndoMed Systems GmbH — EndoMed Systems GmbH · Class IIa
HYSTEROSCOPE — Henke-Sass, Wolf GmbH · Class IIa
Hys. 027.00.3020a 40k — Blazejewski MEDI-TECH GmbH · Class IIa
Single-use Digital Hysteroscope — Zhejiang Geyi Medical Instrument Co., Ltd. · Class IIa
Hysteroscope — Innoview GmbH · Class IIa
Hys. 029.15.3020a — Blazejewski MEDI-TECH GmbH · Class IIa

Cleared under the same submission

K231260 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Suzhou AcuVu Medical Technology Co., Ltd.

Sources (2)

FDA UDI 7eb80184-e91c-4838-a3bf-71194027555b 36 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 1, 2026