FDA Registration Active 🇺🇸 United States

SENSUS HEALTHCARE

Reg #: 3008513398 · FEI: 3008513398 · Expires 2026
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1

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Registration Details

Registration Name
SENSUS HEALTHCARE
Registration Number
3008513398
FEI Number
3008513398
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
851 Broken Sound Pkwy. NW#215
City
Boca Raton
State
FL
ZIP
33487
Country
US

Regulatory Submissions

510(k) Number
K123985

Owner / Operator

Firm Name
Sensus Healthcare
Operator Number
10033258
Address
851 Broken Sound Pkwy. NW#215
City
Boca Raton
State
FL
Postal Code
33487
Country
US
Correspondent
Raul Z Gonzales

Products

Device Name Product Code
System, Therapeutic, X-Ray JAD

Proprietary Names

SRT-100 SRT-100+ SRT-100 Vision

Establishment Types

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