FDA.reportPublic FDA data

XRpad Digital X-Ray Detector System

Primary DI
00812589020085
Brand
XRpad Digital X-Ray Detector System
Company
Perkinelmer, Inc.
Model
XRpad 4343 F MED
Catalog number
95510935-02
Device description
The PerkinElmer XRpad 4343 F MED is a lightweight, 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 18.7 million pixel image matrix, a best-in-class 100 μm pixel pitch, and a direct deposited CsI scintillator, the PerkinElmer XRpad 4343 F MED provides exceptional image quality with a true 43 cm × 43 cm imaging area. A robust and lightweight aluminum frame with carbon-fiber entrance window allows for easier placement and cleaning. Automatic Exposure Detection simplifies integration.
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142698000PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc.2014-10-23MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810751030054PrimaryGS10
00812589020085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810751030054008107510300548107510300540810751030054
00812589020085008125890200858125890200850812589020085

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Millimeter
Length460Millimeter
Weight4.1Kilogram
Width460Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(408) 496-1216mi.customerservice@vareximaging.com
+496123971300MI.CustomerService@PerkinElmer.com
(844) 726-8228MI.CustomerService@PerkinElmer.com

Regulatory Flags#

DUNS number
623897670
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020016PerkinElmer GRNK1 CardDried Blood Spot Collection CardGRNK12022-09-23
00812589020078XRpad Digital X-Ray Detector SystemXRpad 4336 MED95510925-022016-07-29
00812589020092XRpad Digital X-Ray Detector SystemXRpad2 4336 HWC-M955109812017-05-17
00812589020108XRpad Digital X-Ray Detector SystemXRpad2 3025 HWC-M955109912017-05-17
00812589020139XRpad Digital X-Ray Detector SystemXRpad LBC95510921H2016-07-29

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Primary DI, Brand, Company table
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