THE DOME S6C— 510(k) K133609

Substantially Equivalent

Nds Surgical Imaging

FDA 510(k) clearance K133609 for THE DOME S6C, Substantially Equivalent on 2014-02-28. Applicant: Nds Surgical Imaging.

Clearance details

Applicant: Nds Surgical Imaging
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2013-11-25
Decision date: 2014-02-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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.