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DRGEM

Model GXR-EC25 · DRGEM Corporation · DI 08800011110482

IZO — Generator, High-Voltage, X-Ray, Diagnostic · Class I · 21 CFR 892.1700

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.

01122019-04: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.5/device0403
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2023-0301.5
This device (reports/month)Average device in IZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — DRGEM Corporation

  • NAI 2013-04-24 DRGEM CORPORATION · 0 citations
  • NAI 2013-04-24 DRGEM CORPORATION · 0 citations