FDA.reportPublic FDA data

XRpad Digital X-Ray Detector System

Primary DI
00812589020054
Brand
XRpad Digital X-Ray Detector System
Company
PerkinElmer Technologies GmbH & Co. KG
Model
XRpad2 4336 HWC-M
Catalog number
95510981
Device description
XRpad2 4336 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4336 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4336 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
Published
2017-05-17
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812589020054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812589020054008125890200548125890200540812589020054

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
Depth15.5Millimeter
Length460Millimeter
Weight3.2Kilogram
Width384Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(844) 726-8228MI.CustomerService@PerkinElmer.com
+496123971300MI.CustomerService@PerkinElmer.com

Regulatory Flags#

DUNS number
315030809
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812589020061XRpad Digital X-Ray Detector SystemXRpad2 3025 HWC-M955109912017-05-17
00812589020122XRpad Digital X-Ray Detector SystemXRpad LBP95510920H-012016-07-29
00812589020153XRpad Digital X-Ray Detector SystemXRpad IPU95510922H2016-07-29
00812589020160XRpad Digital X-Ray Detector SystemXRpad LPT Detector Cable 10FT-3M 95510931H2016-07-29
00812589020177XRpad Digital X-Ray Detector SystemTrigger Cable, 16.5FT – 5M95510256H2016-07-29
00812589020184XRpad Digital X-Ray Detector SystemTrigger Cable, 65.5FT – 20M95510257H2016-07-29
00812589020214XRpad Digital X-Ray Detector SystemXRpad LPT Detector Cable 20FT-6M95510929H2016-07-29

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Primary DI, Brand, Company table
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