FDA.reportPublic FDA data

MR-RT

Primary DI
00884838068490
Brand
MR-RT
Company
Philips Oy
Model
MR-RT CouchTop
Catalog number
459800573514
Device description
MR-RT is an add-on to the existing Ingenia 1.5T and 3.0T MR systems that makes the system suitable for MR imaging for radiation therapy planning purposes.
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110151000
K214081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110151000ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care2011-03-22LNH
K214081000MRCAT Head & NeckPhilips OY2022-04-05MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838068490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838068490008848380684908848380684900884838068490

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, superconducting magnetA diagnostic general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body (full-body imaging). This system includes a superconducting magnet assembly and can be fixed-location, mobile, or transportable. Some systems can perform MR spectroscopy or various real-time imaging procedures for MRI guided interventional, therapeutic, or surgical applications. The system is available in a variety of system gantry configurations including closed bore, open bore, and open-sided or other kinds of patient accessible designs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)722-9377healthcare@philips.com

Regulatory Flags#

DUNS number
539852079
Device count
1
DM exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838082618Ingenia MR-ORFlextrak OR Ingenia 3T9896030513632016-09-23
00884838094093MR-RTMRCAT Brain / RTgo 4.07814392022-04-26
00884838098206MR-RTMRCAT Brain / RTgo 4.17814392022-04-26
00884838092112RTgoRTgo4598012666332019-06-07
00884838103528MR-RTRT CouchTop XD9896030837512022-08-31
00884838107311MR-RTRTgo 5.03000058063022022-06-14
00884838082625PhilipsFlextrak OR 9896030513432016-09-23
00884838084667RTgo9896030830822018-05-11
00884838068506Geometric QA Phantom4598004389322016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.LNH2026-04-23
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.LNH2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.LNH2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.LNH2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.LNH2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.LNH2026-04-22
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.LNH2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.LNH2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.LNH2026-04-22
B319QSM1QSMetricIMAGING BIOMETRICS, LLCLNH2026-04-22
10841962119457Symphony Locating Bar, Prodigy2™QfixLNH2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixLNH2025-10-23
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12
10841439114787PronumbraMEDTEC, INC.LNH2025-09-12
08056304455727G-scan OpenESAOTE SPALNH2024-07-02
10841962119433Leg ExtensionQfixLNH2023-08-17
10841962119440Leg ExtensionQfixLNH2023-08-17
09355529000002FerriScan, Cardiac T2*RESONANCE HEALTH ANALYSIS SERVICES PTY LTDLNH2023-06-19