myAblation Guide

Primary DI
04068151027273
Brand
myAblation Guide
Company
Siemens Healthcare GmbH
Model
10831405
Catalog number
10831405
Published
2026-08-06
Public version status
Update
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
QTZRadiological Image Processing Software for Ablation Therapy Planning and Evaluation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTZRadiological Image Processing Software For Ablation Therapy Planning And EvaluationRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253264000myAblation Guide (VC10A)Siemens Healthcare GmbH2026-06-16QTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04068151027273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04068151027273040681510272734068151027273

GMDN Terms#

Term, Definition table
TermDefinition
Basic x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

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

Regulatory Flags#

DUNS number
313217003
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
04056869991771myAblation Guide108313732026-05-11
04068151018226syngo Application Software118312342026-05-15
04056869964539syngo Application Software300002672024-11-15
04056869964546syngo Application Software300002662024-01-01
04056869262567syngo Application Software113281802022-10-10
04056869247144syngo Dynamics VA20G107456502019-09-04
04056869247175syngo Dynamics VA20G Packaging Label107456532019-09-04
04056869274645AI-Rad Companion Organs RT115452902021-08-06
04056869257969AI-Rad Companion Organs RT112944332021-02-18
04056869272313syngo Dynamics115521032020-10-29
04056869272320syngo Dynamics115521022020-10-29
04056869256399syngo Dynamics115516432020-07-14
04056869259901syngo Dynamics115518642020-07-14
04056869248653syngo.Interventional113279882020-01-13
04056869124162syngo Application Software113276672020-01-10
04056869253244syngo Dynamics107459602019-12-12
04056869096506syngo.plaza112937242019-05-01
04056869001081syngo.plaza110644362016-09-23
04056869004365syngo.plaza112499522016-09-24
04056869004631syngo MultiModality Workplace104097252016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056869991771myAblation GuideSiemens Healthcare GmbHQTZ2026-05-11
00850009343352MIMMIM SOFTWARE INC.QTZ2026-01-30
00850009343710MIMMIM SOFTWARE INC.QTZ2026-01-30
00860009734814ArtemisEigen Health Services LLCQTZ2026-01-28
00860009734821Artemis-TPOSEigen Health Services LLCQTZ2026-01-28
00850009343321MIMMIM SOFTWARE INC.QTZ2025-05-30
00850009343284MIMMIM SOFTWARE INC.QTZ2024-02-08
00884838107069UroNavPhilips DS North America LLCQTZ2022-07-22