FDA.reportPublic FDA data

PerkinElmer Health Sciences, INC.

Matched from indexed company URL: PerkinElmer Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041898683004189868PerkinElmer Health Sciences, INC.1N2020-04-2523595 Cabot BLVD Suite 106 Hayward CA US 94545
30061599313006159931PERKINELMER Health Sciences, Inc.1N2020-04-25940 WINTER STREET North Waltham MA US 02451
30139442433013944243PerkinElmer Health Sciences Canada, Inc1N2020-04-2532 Nixon Rd Bolton Ontario CA L7E 1W2

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812589020122XRpad Digital X-Ray Detector System - Rechargeable Lithium-Ion Battery for use with PerkinElmer XRpad Detectors and Chargers Only+496123971300MI.CustomerService@PerkinElmer.com
00812589020122XRpad Digital X-Ray Detector System - Rechargeable Lithium-Ion Battery for use with PerkinElmer XRpad Detectors and Chargers Only(844) 726-8228MI.CustomerService@PerkinElmer.com
00812589020153XRpad Digital X-Ray Detector System - Medical grade power supply with interfaces to integrate a PerkinElmer XRpad detector into an X-ray system+496123971300MI.CustomerService@PerkinElmer.com
00812589020153XRpad Digital X-Ray Detector System - Medical grade power supply with interfaces to integrate a PerkinElmer XRpad detector into an X-ray system(844) 726-8228MI.CustomerService@PerkinElmer.com
00812589020160XRpad Digital X-Ray Detector System - 3m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)+496123971300MI.CustomerService@PerkinElmer.com
00812589020160XRpad Digital X-Ray Detector System - 3m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)(844) 726-8228MI.CustomerService@PerkinElmer.com
00812589020177XRpad Digital X-Ray Detector System - 5m Trigger Cable for use with PerkinElmer XRpad IPU+496123971300MI.CustomerService@PerkinElmer.com
00812589020177XRpad Digital X-Ray Detector System - 5m Trigger Cable for use with PerkinElmer XRpad IPU(844) 726-8228MI.CustomerService@PerkinElmer.com
00812589020184XRpad Digital X-Ray Detector System - 20m Trigger Cable for use with PerkinElmer XRpad IPU+496123971300MI.CustomerService@PerkinElmer.com
00812589020184XRpad Digital X-Ray Detector System - 20m Trigger Cable for use with PerkinElmer XRpad IPU(844) 726-8228MI.CustomerService@PerkinElmer.com
00812589020214XRpad Digital X-Ray Detector System - 6m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)+496123971300MI.CustomerService@PerkinElmer.com
00812589020214XRpad Digital X-Ray Detector System - 6m cable to connect PerkinElmer XRpad Detector to XRpad IPU (Interface Power Unit)(844) 726-8228MI.CustomerService@PerkinElmer.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
267061123103940K173829NeoLSD MSMS kitPQW2018-07-18
267061297540797K173568NeoBase 2 Non-derivatized MSMS KitNQL2018-09-04
267061009376700K083130NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040NQL2009-07-09
267061327320765DEN040002NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970NQL2004-08-24
267061974278333BK100008
2360971171754403
2360971190823926
2360971292236258
2360971298181924
2360971333138177
2360971404695248
2360971643672958
2360971722265110
2360971748996395
2107421920125955
2360972004970738

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NQL32018-09-04
PQW12018-07-18

PMA#

PMN#

GUDID#

XRpad Digital X-Ray Detector System - XRpad2 3025 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 3025 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 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.

PerkinElmer Technologies GmbH & Co. KG

2017-05-17

XRpad Digital X-Ray Detector System - 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.

PerkinElmer Technologies GmbH & Co. KG

2017-05-17

XRpad Digital X-Ray Detector System - XRpad2 3025 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 3025 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 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.

Perkinelmer, Inc.

2017-05-17

XRpad Digital X-Ray Detector System - 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.

Perkinelmer, Inc.

2017-05-17

XRpad Digital X-Ray Detector System - 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.

Perkinelmer, Inc.

2016-07-29

XRpad Digital X-Ray Detector System - 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.

Perkinelmer, Inc.

2016-07-29