Skip to content

Jetstream Workspace

by Adac Laboratories 2 variants

510(k) K061029

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 NumberK061029 Date1 May 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0852-2021 FDA Class II initiated 19 Nov 2020

    A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Adac Laboratories

See all devices from Adac Laboratories →