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ADX6000; iRay A6

Model ADX6000 · DEXCOWIN CO., LTD. · DI 08800000500027

MUH — System, X-Ray, Extraoral Source, Digital · Class II · 21 CFR 872.1800

UDILibrary device dossier · generated 2026-09-11 · 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.

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2023-08	0	2
2023-10	0	1
2026-02	0	1
2026-04	0	1

This device (reports/month)Average device in MUH (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Manufacturer compliance record — DEXCOWIN CO., LTD.

Warning Letter 2018-02-20 Dexcowin Co. Ltd.
Warning Letter 2018-02-20 Dexcowin Co. Ltd.
Warning Letter 2015-08-15 Dexcowin Co. Ltd.
Warning Letter 2015-08-15 Dexcowin Co. Ltd.

VAI 2023-02-23 Dexcowin Co. Ltd. · 1 citations
VAI 2023-02-23 Dexcowin Co. Ltd. · 1 citations
NAI 2019-06-06 Dexcowin Co. Ltd. · 0 citations
NAI 2019-06-06 Dexcowin Co. Ltd. · 0 citations
OAI 2017-08-31 Dexcowin Co. Ltd. · 16 citations
OAI 2017-08-31 Dexcowin Co. Ltd. · 16 citations
OAI 2015-03-26 Dexcowin Co. Ltd. · 8 citations
OAI 2015-03-26 Dexcowin Co. Ltd. · 8 citations
VAI 2011-06-03 Dexcowin Co. Ltd. · 0 citations
VAI 2011-06-03 Dexcowin Co. Ltd. · 0 citations