FDA.reportPublic FDA data

Head Array MR Coil Kit

Primary DI
04056869049656
Brand
Head Array MR Coil Kit
Company
Siemens Shenzhen Magnetic Resonance Ltd.
Model
10019258
Device description
Contains Medical Device Mat. 8635554 (GTIN:04056869038797)
Published
2016-09-24
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041111000
K043030000
K082331000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041111000MAGNETOM C! MR SYSTEMSiemens Medical Solutions USA, Inc.2004-07-16LNH
K043030000MAGNETOM C! MR SYSTEMSiemens Medical Solutions2004-12-09LNH
K082331000MAGNETOM C!Siemens Medical Solutions USA, Inc.2008-10-01LNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869049656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869049656040568690496564056869049656

GMDN Terms#

Term, Definition table
TermDefinition
Full-body MRI system, permanent magnetA general-purpose magnetic resonance imaging (MRI) system designed to scan any targeted area of the body. It includes a permanent magnet assembly and can be fixed-location, mobile, or transportable. In addition to producing conventional MR images, it can be designed or modified through additional software/hardware to perform MR spectroscopy and other real-time imaging procedures necessary for physiologically gated imaging procedures, or MRI mammography and other MRI guided interventional, therapeutic, or surgical applications. It is available in a variety of gantry configurations including closed bore, open bore, open-sided or other 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

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Primary DI, Brand, Company table
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04573596201411OASISFUJIFILM CORPORATIONLNH2026-05-29
04573596201435OASISFUJIFILM CORPORATIONLNH2026-05-29
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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
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