FDA 510(k)

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

N.º K: K232738 · 2024-05-31

SolicitantePtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla

Fecha de decisión2024-05-31

Código de productoIYE

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is the device name listed in this FDA 510(k) record. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. It received FDA 510(k) clearance on 2024-05-31 under 510(k) number K232738. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is a medical device that received FDA 510(k) clearance on 2024-05-31. The listed applicant is Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. The 510(k) number is K232738.

When did BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) receive FDA 510(k) clearance?

BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) received FDA 510(k) clearance on 2024-05-31, under 510(k) number K232738.

Who is the listed applicant for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

The FDA 510(k) record lists Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)?

The FDA product code for BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) is IYE.

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Fuente oficial

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