Prelude

FDA UDI

Class I (US FDA UDI)

by MedCom Gesellschaft für medizinische Bildverarbeitung mbH

Identity

Trade Name: Prelude FDA UDI
Generic Name: Radiation therapy software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: V1. FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 04260308110078 FDA UDI
510(k) Number: K180308 FDA UDI
FDA Product Code: LHO FDA UDI
MUJ FDA UDI
GMDN Term: Radiation therapy software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1940 FDA UDI
892.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiation therapy software

Prelude by MedCom Gesellschaft für medizinische Bildverarbeitung mbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K180308 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: MedCom Gesellschaft für medizinische Bildverarbeitung mbH

Sources (1)

FDA UDI c454c0c6-b6e6-4956-bcdc-9016bf97c3f5 34 fields · synced May 30, 2026