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FDA 510(k)

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100

K-Number: K123985 · 2013-05-14

ApplicantSensus Healthcare
Decision Date2013-05-14
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 is the device name listed in this FDA 510(k) record. The listed applicant is Sensus Healthcare. It received FDA 510(k) clearance on 2013-05-14 under 510(k) number K123985. 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 HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100?

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 is a medical device that received FDA 510(k) clearance on 2013-05-14. The listed applicant is Sensus Healthcare. The 510(k) number is K123985.

When did SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 receive FDA 510(k) clearance?

SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 received FDA 510(k) clearance on 2013-05-14, under 510(k) number K123985.

Who is the listed applicant for SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100?

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

What is the FDA product code for SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100?

The FDA product code for SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 is JAD.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sensus Healthcare 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.

K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM

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.K182641Sensus IORT SystemSensus 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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