JETSTREAM WORKSPACE— 510(k) K042880

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K042880 for JETSTREAM WORKSPACE, Substantially Equivalent on 2004-11-03. Applicant: Adac Laboratories. Device class: 2.

Clearance details

Applicant: Adac Laboratories
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-10-19
Decision date: 2004-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Adac Laboratories

K062298 — APOLLO GAMMA CAMERA SYSTEM2006-08-23
K061029 — JETSTREAM WORKSPACE2006-05-01
K060020 — AUTOQUANT PLUS2006-01-20
K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM2005-06-08
K042903 — AUTOSPECS2004-10-29

Recalls naming K042880

K-number listed on FDA's recall record

Z-0852-2021 — Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.Class II·Terminated·Philips North America, LLC·20201119

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042880.

Data sourced from openFDA. This site is unofficial and independent of the FDA.