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Unnamed device
Model Semiflex 0.125 cm³ ion chamber · PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH · DI EPTWTW310100
LHN — System, Radiation Therapy, Charged-Particle, Medical · Class II · 21 CFR 892.5050
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2020-06
0
1
2020-10
0
2
2020-11
0
2
2020-12
0
8
2021-01
0
9
2021-02
0
6
2021-03
0
1
2022-02
0
1
2022-05
0
1
2022-06
0
1
2022-11
0
1
2022-12
0
1
2023-04
0
1
2024-02
0
1
2024-05
0
1
2025-01
0
2
2025-12
0
1
2026-01
0
1
2026-03
0
12
2026-06
0
2
This device (reports/month)Average device in LHN (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K972212 — cited as predicate by K112981
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH