.decimal Proton Range Compensator
Model 2.8 · DECIMAL, INC. · DI 00851147007014
IXI — Block, Beam-Shaping, Radiation Therapy · Class II · 21 CFR 892.5710
UDILibrary device dossier · generated 2026-09-14 · 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.
No dated reports to chart.
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K071078 — cited as predicate by K121657
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — DECIMAL, INC.
- NAI 2025-07-10 Decimal LLC · 0 citations
- NAI 2022-11-09 Decimal LLC · 0 citations
- VAI 2018-02-23 Decimal LLC · 3 citations
- VAI 2015-05-01 Decimal LLC · 0 citations
- VAI 2012-06-29 Decimal LLC · 6 citations