INREACH PLANNING LAPTOP— 510(k) K082386

Name: FDA 510(k) clearance K082386
Creator: U.S. Food and Drug Administration
Published: 2008-09-16

Substantially Equivalent

Superdimension, Ltd.

FDA 510(k) clearance K082386 for INREACH PLANNING LAPTOP, Substantially Equivalent on 2008-09-16. Applicant: Superdimension, Ltd.. Device class: 2.

Clearance details

Applicant: Superdimension, Ltd.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2008-08-19
Decision date: 2008-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Superdimension, Ltd.

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K102604 — I-LOGIC INREACH SYSTEM2010-10-07
K092365 — INREACH SYSTEM, MODEL AAS00161-022009-09-04
K081379 — MODIFICATION TO INREACH SYSTEM2008-06-11
K080271 — INREACH SYSTEM2008-03-31
K071473 — MODIFICATION TO SUPERDIMENSION/BRONCHUS PREMIUM 22007-07-12

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 →

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