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Clarity®

FDA UDI

Class II (US FDA UDI)

by Elekta Inc.

Identity

Trade Name
Clarity® FDA UDI
Generic Name
Ultrasound patient positioning system FDA UDI
Device Name
Clarity® Software FDA UDI
Model / Reference
9310-00043 FDA UDI
Description
Clarity® Software FDA UDI

Identifiers

Primary DI / UDI-DI
07540180000207 FDA UDI
510(k) Number
K141855 FDA UDI
FDA Product Code
KPQ FDA UDI
IYE FDA UDI
IWB FDA UDI
GMDN Term
Ultrasound patient positioning system FDA UDI

Classification

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ultrasound patient positioning system

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

Similar devices

Also classified as Ultrasound patient positioning system.

Cleared under the same submission

K141855 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Elekta Inc.

Sources (1)

  • FDA UDI 314ac809-7753-44a6-acf6-8d167b64e0a6 35 fields · synced Jun 6, 2026