XRpad Digital X-Ray Detector System

FDA UDI

Class II (US FDA UDI)

by Perkinelmer, Inc.

Identity

Trade Name: XRpad Digital X-Ray Detector System FDA UDI
Generic Name: Flat panel x-ray detector integration unit FDA UDI
Device Name: The PerkinElmer XRpad 4336 MED is a wireless, light weight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 15 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a directly deposited CsI scintillator, the PerkinElmer XRpad 4336 MED provides exceptional image quality. True 35 cm × 43 cm imaging area per the ISO 4090 cassette standard is provided, along with a removable, rechargeable battery. A robust and lightweight aluminum frame with carbon-fiber entrance window and back cover allow for easier placement and cleaning. Automatic Exposure Detection simplifies integration. FDA UDI
Model / Reference: XRpad 4336 MED FDA UDI
Description: The PerkinElmer XRpad 4336 MED is a wireless, light weight, cassette-sized flat panel detector for digital radiography. It fits into a conventional table or wall-stand bucky, just like a film-screen cassette. Featuring a 15 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a directly deposited CsI scintillator, the PerkinElmer XRpad 4336 MED provides exceptional image quality. True 35 cm × 43 cm imaging area per the ISO 4090 cassette standard is provided, along with a removable, rechargeable battery. A robust and lightweight aluminum frame with carbon-fiber entrance window and back cover allow for easier placement and cleaning. Automatic Exposure Detection simplifies integration. FDA UDI

Identifiers

Catalog Number: 95510925-02 FDA UDI
Primary DI / UDI-DI: 00812589020078 FDA UDI
FDA Product Code: MQB FDA UDI
GMDN Term: Flat panel x-ray detector integration unit 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 3.8 Kilogram FDA UDI
Width — 384 Millimeter FDA UDI
Length — 460 Millimeter FDA UDI
Depth — 15 Millimeter FDA UDI

Category: Flat panel x-ray detector integration unit

XRpad Digital X-Ray Detector System by Perkinelmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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XRpad Digital X-Ray Detector System — PerkinElmer Technologies GmbH & Co. KG · Class II
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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: Perkinelmer, Inc.

Sources (1)

FDA UDI d28037c7-169e-434e-bc65-6b9b130d56b0 37 fields · synced May 30, 2026