510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hinacom Software and Technology, Ltd.

Haidian District Beijing, CN

HINACOM SOFTWARE AND TECHNOLOGY, LTD. appears in FDA device records in Haidian District Beijing, 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 Hinacom Software and Technology, Ltd. between 2013 and 2018. The busiest year on record is 2013, with 1. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hinacom Software and Technology, Ltd., by decision year
YearClearances
20131
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerLLZSubstantially Equivalent
K131424MIPLATFORM MEDICAL IMAGING SUITELLZSubstantially Equivalent

Registered establishments

FDA registered establishments for Hinacom Software and Technology, Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30106268223010626822HINACOM SOFTWARE AND TECHNOLOGY, LTD.R&D Plaza B1107, Tsinghua Science Park, Haidian District Beijing 100084 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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