DGSCOPE, RELEASE 1.0— 510(k) K070397

Name: FDA 510(k) clearance K070397
Creator: U.S. Food and Drug Administration
Published: 2007-04-13

Substantially Equivalent

Segami Corporation

FDA 510(k) clearance K070397 for DGSCOPE, RELEASE 1.0, Substantially Equivalent on 2007-04-13. Applicant: Segami Corporation. Device class: 2.

Clearance details

Applicant: Segami Corporation
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2007-02-12
Decision date: 2007-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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K071584 — OASIS RELEASE 1.02007-08-31
K070683 — MIRAGE CEDARS OPTION2007-04-12
K043441 — MIRAGE, RELEASE 5.52005-01-13

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.