510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wuhan United Imaging Healthcare Co.,Ltd.

Wuhan Hubei, CN

Wuhan United Imaging Healthcare Co.,Ltd. appears in FDA device records in Wuhan Hubei, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Wuhan United Imaging Healthcare Co.,Ltd. in 2026.

Clearances by year, as a table
510(k) clearance decisions for Wuhan United Imaging Healthcare Co.,Ltd., by decision year
YearClearances
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253720uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace EliteIYNSubstantially Equivalent
K253716uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus SuperIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Wuhan United Imaging Healthcare Co.,Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30219709963021970996Wuhan United Imaging Healthcare Co.,Ltd.No.99 Gaokeyuan Road, East Lake High-tech Development Zone, Wuhan Hubei 430206 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain