FDA.reportPublic FDA data

Prelude

Primary DI
04260308110078
Brand
Prelude
Company
MedCom Gesellschaft für medizinische Bildverarbeitung mbH
Model
V1.
Device description
The Prelude software supports intra-operative radiation therapy workflows with intra-operative radiation devices like IntraOp Mobetron.It assists to find product specific machine parameters for treatment and can send those proposals to the intra-operative radiation device.The machine parameters are not intended to be used for direct control for the radiation device.Machine Output Quality can be visualized and recorded over time for quality assurance.
Published
2020-06-02
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
LHOInstrument, Quality-Assurance, Radiologic
MUJSystem, Planning, Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180308000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180308000PreludeMedcom GmbH2018-03-27MUJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260308110078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260308110078042603081100784260308110078

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Regulatory Flags#

DUNS number
537689275
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260308110092Prelude V1. IORT2022-10-05
04260308110108Prelude V1. EBRT2022-10-05
04260308110023VeriSuite1.82016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069485RadiCSEIZO CORPORATIONLHO2026-09-04
04995047071655RadiCSEIZO CORPORATIONLHO2026-09-04
04995047071662RadiCSEIZO CORPORATIONLHO2026-09-04
00860007402395TrueFit BolusAdaptiiv Medical Technologies IncMUJ2026-06-24
04068151027280syngo.via RT Image Suite VC10Siemens Healthcare GmbHMUJ2026-06-24
00859032007361Panther OISProwess, Inc.MUJ2026-06-09
00859032007378Panther TPSProwess, Inc.MUJ2026-06-09
00884838123786Multimodality Simulation Workspace (MM Sim)1.0Philips Medical Systems Nederland B.V.MUJ2026-06-07
00884838123793Multimodality Simulation Workspace (MM Sim)1.0 UpgradePhilips Medical Systems Nederland B.V.MUJ2026-06-07
00859032007316Panther TPSProwess, Inc.MUJ2026-06-01
00859032007323Panther TPSProwess, Inc.MUJ2026-06-01
00859032007330Panther OISProwess, Inc.MUJ2026-06-01
00859032007347Panther TPSProwess, Inc.MUJ2026-06-01
00859032007354Panther OISProwess, Inc.MUJ2026-06-01
05060608881499RapidCHECKSUN NUCLEAR CORP.LHO2026-05-10
00860015780805INTContourCarina Medical LLCMUJ2026-04-27
EPTWT20020Q1Q1000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q1100COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q1300COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q2000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q3000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q3100COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q4000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41018Q1Q0100MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41018Q1Q0120MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0040MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0050MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0060MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0070MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0120MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16