JETSTREAM WORKSPACE— 510(k) K061029

Name: FDA 510(k) clearance K061029
Creator: U.S. Food and Drug Administration
Published: 2006-05-01

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K061029 for JETSTREAM WORKSPACE, Substantially Equivalent on 2006-05-01. Applicant: Adac Laboratories. Device class: 2.

Clearance details

Applicant: Adac Laboratories
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2006-04-14
Decision date: 2006-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Adac Laboratories

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K062298 — APOLLO GAMMA CAMERA SYSTEM2006-08-23
K060020 — AUTOQUANT PLUS2006-01-20
K051351 — PRECEDENCE SPECT/CT IMAGING SYSTEM2005-06-08
K042880 — JETSTREAM WORKSPACE2004-11-03
K042903 — AUTOSPECS2004-10-29

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K061029

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 K061029.

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