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Model AJX500 · Guangzhou Ajax Medical Equipment Co., Ltd. · DI 06971608311826

EHD — Unit, X-Ray, Extraoral With Timer · Class II · 21 CFR 872.1800

UDILibrary device dossier · generated 2026-09-06 · 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.

11222019-01: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device01060212021208100204
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0602
2020-0202
2021-1201.33
2022-0201
2022-1202
2023-0802
2023-1001
2026-0201
2026-0401
This device (reports/month)Average device in EHD (reports/device/month)

Regulatory clearances

  • K252110 SESE 2026-03-12 (k number procode)

Predicate lineage

K252110 — cites (transitively): K200182 (d1), K161063 (d2), K081664 (d3)

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

Manufacturer compliance record — Guangzhou Ajax Medical Equipment Co., Ltd.

Nothing in the loaded window.