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510(k) K190255

Sensus Healthcare TVM Balloon Applicator by Sensus Healthcare, Inc. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2019
Date Received
February 7, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

Other clearances by Sensus Healthcare, Inc.

  • K182641 — Sensus IORT System (February 21, 2019)
  • K182665 — Sensus TPS Workstation (February 21, 2019)
  • K173425 — SRT-100+ (March 23, 2018)
  • K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Ima (October 16, 2015)
  • K131582 — SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM (August 28, 2013)
  • K123985 — SENSUS HEALTHCARE SUPERFICIAL RADIOTHERAPY SYSTEM SRT-100 (May 14, 2013)

Other clearances for product code JAD

  • K250692 — GentleBeam (GB1000) (December 3, 2025)
  • K241174 — INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spheric (January 10, 2025)
  • K230611 — X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) (July 13, 2023)
  • K213942 — Esteya (January 11, 2022)
  • K182641 — Sensus IORT System (February 21, 2019)
  • K173425 — SRT-100+ (March 23, 2018)
  • K172080 — Photoelectric Therapy System (September 29, 2017)
  • K162568 — INTRABEAM 600 (December 15, 2016)
  • K153570 — Axxent Electronic Brachytherapy System Model 110 XP 1200 (February 25, 2016)
  • K150037 — Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Ima (October 16, 2015)