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Endopro Iq

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
ENDOPRO IQ FDA UDI
Generic Name
Diagnostic imaging telemedicine system FDA UDI
Device Name
HITACHI SONOELASTOG SOFTWR/HV PREIRUS-B FDA UDI
Model / Reference
M70228 FDA UDI
Description
HITACHI SONOELASTOG SOFTWR/HV PREIRUS-B FDA UDI

Identifiers

Primary DI / UDI-DI
04961333243891 FDA UDI
510(k) Number
K093466 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Diagnostic imaging telemedicine system FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Diagnostic imaging telemedicine system

Endopro Iq by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic imaging telemedicine system.

Cleared under the same submission

K093466 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA UDI 5d153acc-17ae-4785-adf5-def663e232dd 34 fields · synced May 30, 2026