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Decision Support System (for Radiation Oncology)

by Multidata Systems International Corp.

510(k) K964167

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 NumberK964167 Date21 Mar 1997ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0985-02 FDA Unclassified (pre-2012) initiated 10 Nov 2002 on shared 510(k) K964167

    The units lacked the required labels per the laser performace standard.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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