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Clarity®

FDA UDI

Class II (US FDA UDI)

by Elekta Solutions AB

Identity

Trade Name
Clarity® FDA UDI
Generic Name
Ultrasound patient positioning system FDA UDI
Device Name
Clarity® Digitizer FDA UDI
Model / Reference
9100-00041 FDA UDI
Description
Clarity® Digitizer FDA UDI

Identifiers

Primary DI / UDI-DI
07540180000108 FDA UDI
FDA Product Code
KPQ FDA UDI
IWB FDA UDI
IYE FDA UDI
GMDN Term
Ultrasound patient positioning system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5840 FDA UDI
892.5750 FDA UDI
892.5050 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

No

FDA UDI

Category: Ultrasound patient positioning system

Clarity® by Elekta Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ultrasound patient positioning system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elekta Solutions AB

Sources (1)

  • FDA UDI 71288fb5-634b-4a99-91d2-1049b777b575 35 fields · synced Jun 6, 2026