MRI Planner

Primary DI
07350097430017
Brand
MRI Planner
Company
Spectronic Medical AB
Model
2
Device description
MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software also performs automated contouring of risk organs in certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is supported for bladder, colon and femoral heads for prostate cancer patients only.
Published
2023-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350097430017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350097430017073500974300177350097430017

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy planning softwareA software program intended to display and analyse/process images, typically acquired via computed tomography (CT), to assist with a brachytherapy and/or noninvasive radiation therapy procedure (radiosurgery). It is typically intended for treatment planning (e.g., organ contouring) and/or quality assurance of the dose delivery. It does not incorporate adaptive/dynamic machine learning (ML) models.

Contacts#

Phone, Email table
PhoneEmail
+4642252000support@spectronic.se

Regulatory Flags#

DUNS number
427673314
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

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