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FDA 510(k)

Sensus IORT System

K-Number: K182641 · 2019-02-21

ApplicantSensus Healthcare, Inc.
Decision Date2019-02-21
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sensus IORT System is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare, Inc.. It received FDA 510(k) clearance on 2019-02-21 under 510(k) number K182641. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sensus IORT System?

Sensus IORT System is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Sensus Healthcare, Inc.. The 510(k) number is K182641.

When did Sensus IORT System receive FDA 510(k) clearance?

Sensus IORT System received FDA 510(k) clearance on 2019-02-21, under 510(k) number K182641.

Who is the listed applicant for Sensus IORT System?

The FDA 510(k) record lists Sensus Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sensus IORT System?

The FDA product code for Sensus IORT System is JAD.

Other records listing Sensus Healthcare, Inc. 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.

K190255Sensus Healthcare TVM Balloon ApplicatorK182665Sensus TPS WorkstationK173425SRT-100+

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K173425SRT-100+Sensus Healthcare, Inc.

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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