iSR'obot MRI-US Fusion— 510(k) K161109

Substantially Equivalent

Biobot Surgical Pte., Ltd.

FDA 510(k) clearance K161109 for iSR'obot MRI-US Fusion, Substantially Equivalent on 2016-10-06. Applicant: Biobot Surgical Pte., Ltd..

Clearance details

Applicant: Biobot Surgical Pte., Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-04-20
Decision date: 2016-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

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.