PICA Whole-body MRI System

GUDID 00862694000304

TIME MEDICAL SYSTEMS

Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet Full-body MRI system, permanent magnet
Primary Device ID00862694000304
NIH Device Record Keyddacc532-6311-4607-a3f8-589dea246964
Commercial Distribution StatusIn Commercial Distribution
Brand NamePICA Whole-body MRI System
Version Model NumberTMS-MRI-3500wb-02
Company DUNS020884437
Company NameTIME MEDICAL SYSTEMS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com
Phone+1 858-458-0166
Emailsales@time-medical.com

Device Dimensions

Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram
Weight18500 Kilogram

Operating and Storage Conditions

Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 20 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100862694000304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

Devices Manufactured by TIME MEDICAL SYSTEMS

00862694000328 - NEONA 1.5T MRI System2023-03-30
00862694000311 - EMMA 1.5T MRI System2023-03-24
00862694000304 - PICA Whole-body MRI System2018-07-06
00862694000304 - PICA Whole-body MRI System2018-07-06

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