FDA.reportPublic FDA data

PLANET Onco Dose

Primary DI
B501PLANET030200
Brand
PLANET Onco Dose
Company
DOSISOFT
Model
3.2
Catalog number
PL1100
Device description
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, contouring, internal dosimetry computation and therapy response assessment, using molecular imaging modalities.
Published
2025-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241765000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241765000PLANET Onco Dose (3.2)Dosisoft SA2025-03-14LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B501PLANET030200PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264815932
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B501THINKQA0200020ThinkQA Edition 22.0.22024-08-22
B501THINKQA0200000ThinkQA Edition 22.0.0TK2010, TK20202024-08-14
B501THINKQA0200010ThinkQA Edition 22.0.1TK2010, TK20202024-08-14
B501EPIGRAY020010EPIgray2.0.10EP10012023-06-30
B501THINKQA010006ThinkQA, EPIbeam1.0.6EP10112023-06-30
B501PLANET030101PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose3.1.13.1.12020-01-30
B501MU2NET020101MU2net2.1.12.1.12019-11-19
B501EPIGRAY020007EPIgray2.0.72.0.72019-08-07
B501THINKQA010004ThinkQA, EPIbeam1.0.41.0.42019-08-07
B501EPIGRAY020006EPIgray2.0.62.0.62017-04-10
B501THINKQA010002ThinkQA, EPIbeam1.0.21.0.22018-04-18

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Primary DI, Brand, Company table
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B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
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05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20