Careray Digital Medical Technology Co., Ltd.

FDA Regulatory Profile

Careray Digital Medical Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 16, 2017 · NAI
Latest 510(k)
Aug 3, 2023

Updated: recalls Oct 23, 2026 · inspections Oct 23, 2026 · compliance actions Oct 23, 2026.

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Summary

Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 16, 2017Suzhou, ChinaDevicesNo Action Indicated (NAI)3011158427

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K232058YosemiteView 4343W/YosemiteView 3643WAug 3, 2023
K223687X-ray Flat Panel Detectors (EverestView 4343X)Dec 30, 2022
K221549X-ray Flat Panel Detectors (CareView 1800 RF)Aug 1, 2022