Skip to content

Jetstream Workspace

by Adac Laboratories 2 variants

510(k) K042880

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 NumberK042880 Date3 Nov 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0852-2021 FDA Class II initiated 19 Nov 2020 on shared 510(k) K042880

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

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  • Withdrawn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
KPS
Device Class
Class II
Regulation
21 CFR Part 892.1200
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Adac Laboratories

See all devices from Adac Laboratories →