510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sensus Healthcare

Boca Raton, FL, US

SENSUS HEALTHCARE appears in FDA device records in Boca Raton, FL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
7
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Sensus Healthcare between 2013 and 2019. The busiest year on record is 2019, with 3. The most recent is 2019, with 3.

Clearances by year, as a table
510(k) clearance decisions for Sensus Healthcare, by decision year
YearClearances
20132
20151
20181
20193
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K190255Sensus Healthcare TVM Balloon ApplicatorJADSubstantially Equivalent
K182665Sensus TPS WorkstationMUJSubstantially Equivalent
K182641Sensus IORT SystemJADSubstantially Equivalent
K173425SRT-100+JADSubstantially Equivalent
K150037Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesJADSubstantially Equivalent
K131582SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEMJADSubstantially Equivalent
K123985SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100JADSubstantially Equivalent

Registered establishments

FDA registered establishments for Sensus Healthcare, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30085133983008513398SENSUS HEALTHCARE851 Broken Sound Pkwy. NW#215, Boca Raton, FL 33487 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1235-2023Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging CapabilitiesWhen the user pauses the beam delivery, the dose timer is reset (to zero), and as a result may deliver an unexpected dose to the patient.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain