AXIOM SIRESKOP SD— 510(k) K051602

Name: FDA 510(k) clearance K051602
Creator: U.S. Food and Drug Administration
Published: 2005-07-07

Substantially Equivalent

Siemens Medical Systems, Inc.

FDA 510(k) clearance K051602 for AXIOM SIRESKOP SD, Substantially Equivalent on 2005-07-07. Applicant: Siemens Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Siemens Medical Systems, Inc.
Product code: Code JAA
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2005-06-16
Decision date: 2005-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mavern, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JAA

product code JAA

Other: 1
Total: 1

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 K051602

K-number listed on FDA's recall record

Z-1000-2023 — AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRFClass II·Ongoing·Siemens Medical Solutions USA, Inc·20221209

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051602.

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