MR 5300, MR 7700 & Ingenia 782142

GUDID 00884838108653

Upgrades dStream to R11

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet
Primary Device ID00884838108653
NIH Device Record Keyc9df5b2c-56cb-45e5-8411-fa640cb12095
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR 5300, MR 7700 & Ingenia
Version Model NumberUpgrades dStream to R11
Catalog Number782142
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100884838108653 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

Devices Manufactured by Philips Medical Systems Nederland B.V.

00884838101135 - Ingenia, MR 53002025-09-30 R5.7 brings software and application improvements. These include SmartExam enhancements with Quick Smart Survey. Other SW enhanc
00884838108653 - MR 5300, MR 7700 & Ingenia2025-09-30Upgrades dStream to R11
00884838108653 - MR 5300, MR 7700 & Ingenia2025-09-30 Upgrades dStream to R11
00884838108684 - Achevia2025-09-30 SmartPath to dStream integrates dStream architecture on the current 3.0T magnet, providing flexible and intelligent tools for fa
00884838108714 - Ingenia2025-09-30 Upgrade to the next generation portfolio for our customers having an Ingenia 1.5T (S)
00884838115668 - MR 77002025-09-26 MR 7700 extends the gradient and RF designs with extreme gradient performance to deliver superb image quality in diffusion and n
00884838115682 - Ingenia2025-09-26 Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extrem
00884838124325 - Philips IntelliSite Pathology Solution2025-09-09 Whole Slide Imaging System. The device is an automated digital slide creation, viewing, and management system.
00884838124349 - Philips IntelliSite Pathology Solution2025-09-09 Whole Slide Imaging System. The device is an automated digital slide creation, viewing and management system

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