FDA.reportPublic FDA data

PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose

Primary DI
B501PLANET030101
Brand
PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose
Company
DOSISOFT
Model
3.1.1
Catalog number
3.1.1
Device description
PLANET Onco Dose is a software platform dedicated to medical diagnosis aid, therapy response assessment aid, contouring for radiotherapy and internal dosimetry computation, using molecular imaging modalities.
Published
2020-01-30
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
K182966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182966000PLANET Onco DoseDosisoft2019-03-06LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B501PLANET030101PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
264815932
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B501PLANET030200PLANET Onco Dose3.2PL11002025-07-17
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
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
Primary DIBrandCompanyProduct codePublished
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04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
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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