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BoS™

FDA UDI

Class II (US FDA UDI)

by Qfix

Identity

Trade Name
BoS™ FDA UDI
Generic Name
Radiation therapy treatment planning positioning kit FDA UDI
Device Name
BoS Headframe MRI Compatible 2nd Generation Stand Alone Unit FDA UDI
Model / Reference
RT-4535BOSMRI FDA UDI
Description
BoS Headframe MRI Compatible 2nd Generation Stand Alone Unit FDA UDI

Identifiers

Catalog Number
RT-4535BOSMRI FDA UDI
Primary DI / UDI-DI
10841962108666 FDA UDI
FDA Product Code
JAI FDA UDI
GMDN Term
Radiation therapy treatment planning positioning kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Radiation therapy treatment planning positioning kit

BoS™ by Qfix — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiation therapy treatment planning positioning kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Qfix

Sources (1)

  • FDA UDI e0bcb64b-ca9d-4b9d-84bb-efb7545f5bc2 35 fields · synced Jun 6, 2026