FDA.reportPublic FDA data

LungMaps

Primary DI
04068151086584
Brand
LungMaps
Company
Siemens Healthineers AG
Model
VA10A
Catalog number
VA10A
Device description
Magnetic Resonance (MR) Systems – Medical Device Software
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LNHSystem, nuclear magnetic resonance imaging
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LNHSystem, Nuclear Magnetic Resonance ImagingRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253690000LungMapsSiemens Healthineers AG2026-06-15QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04068151086584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04068151086584040681510865844068151086584

GMDN Terms#

Term, Definition table
TermDefinition
MRI system application softwareAn individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a magnetic resonance imaging (MRI) system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
314699460
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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
04068151034202syngo Dynamics11708404117084042026-07-16
04068151994995SOMATOM X.cite113300012026-04-07
04068151995008System SOMATOM X.ceed113300022026-04-07
04068151995114MAGNETOM Altea113449152026-02-23
04068151995121MAGNETOM Altea114103712026-02-23
04068151995251MAGNETOM Lumina113449162026-02-23
04068151995268MAGNETOM Lumina115161532026-02-23
04068151995299MAGNETOM Sola112914552026-02-23
04068151995305MAGNETOM Sola114102312026-02-23
04068151995312MAGNETOM Sola Fit114104822026-02-23
04068151995343MAGNETOM Vida110608152026-02-23
04068151995350MAGNETOM Vida115161522026-02-23
04068151995367MAGNETOM Vida Fit115161522026-02-23
04068151995374MAGNETOM Viato.Mobile116896522026-02-23
04068151020472BIOGRAPH One116891722026-01-20

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00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953007716NAGE Medical Systems, L.L.C.LNH2026-10-07
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
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08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
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00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
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00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
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00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.LNH2026-08-23
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
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08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07