Cleared Traditional

BeamDose software (S080053) (K232738) - FDA 510(k) Clearance

Also marketed or referenced as:
BEAMSCAN software, option reference dosimetry (S080054.002)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232738 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Radiology device
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May 2024
Decision
267d
Days
Class 2
Risk

K232738 is an FDA 510(k) clearance for the BeamDose software (S080053). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla (Freiburg, DE). The FDA issued a Cleared decision on May 31, 2024 after a review of 267 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla devices

Submission Details

510(k) Number K232738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2023
Decision Date May 31, 2024
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 227
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