Skip to content

Clarity® 1531854

by Elekta Inc.

Clarity® 1531854 is a Class II device made by Elekta Inc., cleared under FDA 510(k) K141855 on 8 Oct 2014 and listed in FDA GUDID since 22 Jun 2017 (UDI-DI 07540180000191), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K141855

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07540180000191 UDI-DI Date22 Jun 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141855 Date8 Oct 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141855 decided 8 Oct 2014 Active
  • FDA GUDID UDI-DI 07540180000191 listed 22 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K141855
  2. Listed FDA GUDID 07540180000191

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Clarity®
Generic name
Ultrasound patient positioning system
Model / reference
1531854
Primary DI / UDI-DI
07540180000191
510(k) Number
FDA product code
IYE
GMDN term
Ultrasound patient positioning system
Device class
Class II
Regulation number
892.5050
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K141855)

Similar devices

Other devices filed under FDA product code IYE (Accelerator, linear, medical).

Other devices from Elekta Inc.

  • XVI 1526927

    Class II

  • Elekta Unity 1536549

    Class II

  • 1525333

    Class II

  • 1525332

    Class II

See all devices from Elekta Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)