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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Biobot Surgical Pte., Ltd.. It received FDA 510(k) clearance on 2016-10-06 under 510(k) 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. The listed applicant is Biobot Surgical Pte., Ltd.. The 510(k) number is K161109.

When did iSR'obot MRI-US Fusion receive FDA 510(k) clearance?

iSR'obot MRI-US Fusion received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161109.

Who is the listed applicant for iSR'obot MRI-US Fusion?

The FDA 510(k) record lists Biobot Surgical Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Biobot Surgical Pte., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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