iSR'obot MRI-US Fusion
K-Number: K161109 · 2016-10-06
ApplicantBiobot Surgical Pte., Ltd.
Decision Date2016-10-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
iSR'obot MRI-US Fusion is a medical device manufactured by Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2016-10-06 under approval number K161109. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iSR'obot MRI-US Fusion?
iSR'obot MRI-US Fusion is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Biobot Surgical Pte., Ltd.. The 510(k) number is K161109.
When was iSR'obot MRI-US Fusion approved by the FDA?
iSR'obot MRI-US Fusion received FDA 510(k) clearance on 2016-10-06, under approval number K161109.
What company makes iSR'obot MRI-US Fusion?
iSR'obot MRI-US Fusion is manufactured by Biobot Surgical Pte., Ltd..
What is the FDA product code for iSR'obot MRI-US Fusion?
The FDA product code for iSR'obot MRI-US Fusion is LLZ.
Other Devices by Biobot Surgical Pte., Ltd.
Related Devices (Code: LLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.