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Avanza

Model Avanza · Best Theratronics Ltd · DI 07540146000050

JAI — Couch, Radiation Therapy, Powered · Class II · 21 CFR 892.5770

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.

11222024-02: 0 reports for this device; peer average 2/device02
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-0202
This device (reports/month)Average device in JAI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K060870 — cited as predicate by K151469

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Best Theratronics Ltd

  • VAI 2017-01-26 BEST THERATRONICS LTD. · 2 citations