FDA-Device2023-03-15Class II
Sensus 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 Capabilities
Sensus Healthcare, Inc.
Hazard
When 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.
Sold states
US Distribution to states of: RX, IN, NM, FL, NY, FA, NC, IA, and IL.
Affected count
23 units
Manufactured in
851 Broken Sound Pkwy Nw Ste 215, Boca Raton, FL, United States
Products
Sensus 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 Capabilities
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1235-2023Don't want to check this manually?
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