FDA.reportPublic FDA data

dS MSK S 1.5T

Primary DI
00884838133242
Brand
dS MSK S 1.5T
Company
Philips Healthcare (Suzhou) Co., Ltd.
Model
dS MSK S 1.5T
Catalog number
459801682003
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
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00884838133242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838133242008848381332428848381332420884838133242

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.

Regulatory Flags#

DUNS number
421265537
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838111622Smart Fit Shoulder 1.5TSmart Fit Shoulder 1.5T9897100121912026-06-26
00884838112667Smart Fit Knee 3.0TSmart Fit Knee 3.0T9897100122512026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TSmart Fit TorsoCardiac 1.5T9897100121622026-06-26
00884838133235dS MSK M 1.5TdS MSK M 1.5T4598016820132026-06-26
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
00884838096837dS MSK M 1.5TdS MSK M 1.5T45980168201X2022-04-17
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
00884838111622Smart Fit Shoulder 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838112667Smart Fit Knee 3.0TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838131866Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
00884838133235dS MSK M 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
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
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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