FDA.reportPublic FDA data

dS MSK M 1.5T

Primary DI
00884838096837
Brand
dS MSK M 1.5T
Company
Philips Healthcare (Suzhou) Co., Ltd.
Model
dS MSK M 1.5T
Catalog number
45980168201X
Device description
The Device is designed to be used in conjunction with MR Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
Published
2022-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MOSCoil, Magnetic Resonance, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212864000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212864000dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.2021-12-01MOS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838096837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838096837008848380968378848380968370884838096837

GMDN Terms#

Term, Definition table
TermDefinition
MRI system coil, radio-frequencyA radio-frequency (RF) coil acts as a transmitter, receiver, or both a transmitter and receiver of RF pulses necessary for diagnostic magnetic resonance imaging (MRI) procedures. It is used to enhance image resolution by improving signal to noise characteristics. There are two main kinds of RF coils: volume coils (which surround the part of the body being imaged) and surface coils (which are placed and secured directly on or under an area of interest). This group of devices includes a variety RF coil designs and configurations including, e.g., surface coils, phased array coils, paired saddle coils, Hemholtz pair coils or bird cage coils.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421265537
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838129528CT RembraCT Rembra7283832026-04-03
00884838129535CT Rembra RTCT Rembra RT7283812026-04-03
00884838129542CT Areta RTCT Areta RT7283822026-04-03
00884838085015Incisive CTIncisive CT7281432019-10-01
00884838096813dS TorsoCardiac 1.5TdS TorsoCardiac 1.5T45980168199X2022-04-17
00884838113237CT 5300CT 53007282852024-11-11
00884838096820dS MSK S 1.5TdS MSK S 1.5T45980168200X2022-04-17
00884838105508Incisive CTIncisive CT7281442021-12-30
00884838095199DigitalDiagnost C50DigitalDiagnost C507122042020-09-04
00884838095205DuraDiagnostDuraDiagnost7122032020-09-04
00884838064737DuraDiagnost CompactDuraDiagnost Compact7122132016-09-23
00884838064751DuraDiagnostDuraDiagnost7122142016-09-23
00884838082366DigitalDiagnost C50DigitalDiagnost C507122012017-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278925282NAGE HEALTHCARE(TIANJIN) COMPANY LIMITEDMOS2026-05-11
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
00814848020836Contour Hand Wrist 0.55TQUALITY ELECTRODYNAMICS LLCMOS2026-04-23
00850083516000Nuzzle Body Array, 1.5TInkspace Imaging, Inc.MOS2026-04-21
00850083516017Silhouette Body Array – PH 3T (Cherry Blossoms)Inkspace Imaging, Inc.MOS2026-04-21
00860008041371Snuggle Pediatric Array – PH 3T (Dino)Inkspace Imaging, Inc.MOS2026-04-21
00860008041395Nuzzle Body Array – PH 3T (Whimsical)Inkspace Imaging, Inc.MOS2026-04-21
00884838130548DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130555DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130562DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130579DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130586DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130593DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130609DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130616DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838130623DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132597DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838132603DUNLEEPhilips Medical Systems Nederland B.V.MOS2026-04-03
00884838093089MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093096MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838093102MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098190MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098367MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838098510MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838108073MRI CoilsPhilips Ds North America LLCMOS2025-10-01
00884838118997MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838119000MR CoilsPhilips Medical Systems Nederland B.V.MOS2025-10-01
00884838108080MRI CoilsPhilips Ds North America LLCMOS2025-09-30
00884838111172DUNLEEPhilips Medical Systems Nederland B.V.MOS2025-09-30