System, X-Ray, Stationary

FDA UDI

Class II (US FDA UDI)

by Gemss Medical Systems Co., Ltd.

Identity

Trade Name: SYSTEM, X-RAY, STATIONARY FDA UDI
Generic Name: Computed radiography digital imaging scanner FDA UDI
Device Name: TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient. FDA UDI
Model / Reference: TITAN 11 FDA UDI
Description: TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient. FDA UDI

Identifiers

Catalog Number: TITAN 11 FDA UDI
Primary DI / UDI-DI: 08809246620032 FDA UDI
510(k) Number: K133695 FDA UDI
FDA Product Code: KPR FDA UDI
GMDN Term: Computed radiography digital imaging scanner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1680 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Computed radiography digital imaging scanner

System, X-Ray, Stationary by Gemss Medical Systems Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Gemss Medical Systems Co., Ltd.

Sources (1)

FDA UDI ba5b5e31-e721-458c-a64e-f3e2fb537bc1 37 fields · synced Jun 8, 2026