Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008513398

FEI Number

3008513398

Entity Name

SENSUS HEALTHCARE

City/State/Country

Boca Raton, FL, US

Establishment Address

851 Broken Sound Pkwy. NW#215, Boca Raton, FL 33487, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Sensus Healthcare (Owner Number: 10033258)

Owner / Operator Contact Address

851 Broken Sound Pkwy. NW#215, Boca Raton, FL 33487, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150037

PMA Number

N/A

All Registered Proprietary Names

SRT-100 SRT-100+ SRT-100 Vision

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2016-12-16
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2018-05-17
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2016-12-16

Official Correspondent

Raul Gonzales

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sensus Healthcare

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241174	Carl Zeiss Meditec, AG	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	2025-01-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments

Similar Registrations

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3032638959	Elekta Inc.	San Jose, CA, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3030230020	KOPLAK CORP	Sunrise, FL, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008513398. Last updated year: 2026. Please use registration number 3008513398 when referencing this establishment in official correspondence.