FDA.reportPublic FDA data

XRpad Digital X-Ray Detector System

Primary DI
00812589020139
Brand
XRpad Digital X-Ray Detector System
Company
Perkinelmer, Inc.
Model
XRpad LBC
Catalog number
95510921H
Device description
Rechargeable Lithium-Ion Battery Charger for use with PerkinElmer XRpad Battery Only
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812589020139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589020139008125890201398125890201390812589020139

GMDN Terms#

Term, Definition table
TermDefinition
Flat panel x-ray detector integration unitA portable, electrically-powered device intended to enable a direct flat panel detector (not included) to be integrated as part of an analogue x-ray [i.e., screen-film, computerized radiography (plate)] system to convert the analogue x-ray system into a digital x-ray system (retrofit) using the same modality components. It is typically an electronic box which is integrated into the analogue x-ray system via wired connections to each of the components (i.e., generator, exposure button, workstation and detector), whereby it synchronizes the original analogue generator with the direct flat panel detector.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth82Millimeter
Height113Millimeter
Weight1.1Kilogram
Width259Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius42 Degrees Celsius
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
00812589020085XRpad Digital X-Ray Detector SystemXRpad 4343 F MED95510935-022016-07-29
00812589020092XRpad Digital X-Ray Detector SystemXRpad2 4336 HWC-M955109812017-05-17
00812589020108XRpad Digital X-Ray Detector SystemXRpad2 3025 HWC-M955109912017-05-17

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Primary DI, Brand, Company table
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08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
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B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
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