EPIgray

FDA UDI

Class II (US FDA UDI)

by Dosisoft SA

Identity

Trade Name: EPIgray FDA UDI
Generic Name: Radiation therapy software FDA UDI
Device Name: Radiotherapy software quality assurance tool. FDA UDI
Model / Reference: 2.0.6 FDA UDI
Description: Radiotherapy software quality assurance tool. FDA UDI

Identifiers

Catalog Number: 2.0.6 FDA UDI
Primary DI / UDI-DI: B501EPIGRAY020006 FDA UDI
510(k) Number: K112723 FDA UDI
FDA Product Code: MUJ FDA UDI
GMDN Term: Radiation therapy software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Radiation therapy software

EPIgray by Dosisoft SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K112723 also covers:

EPIgray — Dosisoft SA
EPIgray — Dosisoft SA

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 II	Pending data

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Manufacturer

Manufacturer: Dosisoft SA

Sources (1)

FDA UDI aaf290f1-258a-4b41-9ab0-7bbecb716bef 35 fields · synced May 30, 2026