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Iview Electronic Portal Imaging Device (Epid) Model Number Ivew

by Elekta Oncology Systems, Ltd.

510(k) K981790

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981790 Date7 Aug 1998ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1436-2010 FDA Unclassified (pre-2012) initiated 31 Jul 2009

    Image problems that have an effect on patient position corrections and on the accuracy of the radiation treatment.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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