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.decimal Photon Block

Model 1.3 · DECIMAL, INC. · DI 00851147007045

IXI — Block, Beam-Shaping, Radiation Therapy · Class II · 21 CFR 892.5710

UDILibrary device dossier · generated 2026-09-15 · 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

  • K123015 SESE 2012-11-21 (k number procode)

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