FDA.reportPublic FDA data

Shoulder Shape 16 Coil 3T

Primary DI
04056869053424
Brand
Shoulder Shape 16 Coil 3T
Company
Siemens Shenzhen Magnetic Resonance Ltd.
Model
10840785
Device description
MRI Coil
Published
2017-07-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging
LNISystem, nuclear magnetic resonance spectroscopic
MOSCoil, magnetic resonance, specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
LNISystem, Nuclear Magnetic Resonance SpectroscopicRadiology2
MOSCoil, Magnetic Resonance, SpecialtyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170396000MAGNETOM VidaSiemens Medical Solutions USA, Inc.2017-06-14LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869053424PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869053424040568690534244056869053424

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)888-7436XX@XX.XX
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
544891302
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869997926MAGNETOM Flow.Plus115713122025-07-07
04056869997933MAGNETOM Flow.Plus115713132025-07-07
04056869281759MAGNETOM Free.Max114084242022-09-01
04056869281766MAGNETOM Free.Star114084262022-09-01
04056869281773MAGNETOM Free.Star114084272022-09-01
04056869281742MAGNETOM Free.Max114084252021-08-02
04056869996202MAGNETOM Flow.Ace115712472025-07-07
04056869996219MAGNETOM Flow.Ace115712482025-07-07
04056869281926Contour M Coil Set114076772022-09-01
04056869281858Head/Neck Coil114076592021-08-02
04056869281896Head/Neck Coil Set114076602021-08-02
04056869281933Spine Coil114073782021-08-02
04056869281940Spine Coil Set114073772021-08-02
04056869163383Shoulder Shape 16112928052021-07-30
04056869165325Shoulder Shape 16 Coil Set 1.5T112928062021-07-30
04056869231105Flex large 8112931342021-07-30
04056869231112Flex Large 8 Coil Set 1.5T112931332021-07-30
04056869231129BM Body 13114072552021-07-30
04056869231136BM Body 13 MR Coil Set 1.5T114072562021-07-30
04056869231167Flex Small 8 Coil Set 1.5T112931352021-07-30

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
00884838133242dS MSK S 1.5TPhilips Healthcare (Suzhou) Co., Ltd.MOS2026-06-26
04068151086584LungMapsSiemens Healthineers AGLNH2026-06-24
04573596201367OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201398OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201404OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596202159OASISFUJIFILM CORPORATIONLNH2026-05-29
04260486610339NBAC 3.0T PH I FlexLMT Medical Systems GmbHMOS2026-04-28
04260486610605NBAC 1.5T GE P SpineLMT Medical Systems GmbHMOS2026-04-28
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
10841439114732PronumbraMEDTEC, INC.LNH2025-09-12
10841439114749PronumbraMEDTEC, INC.LNH2025-09-12
10841439114770PronumbraMEDTEC, INC.LNH2025-09-12