510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Neusoft Positron Medical Systems Co.,Ltd.

Shen Yang Liaoning, CN

NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD. appears in FDA device records in Shen Yang Liaoning, CN. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Neusoft Positron Medical Systems Co.,Ltd. in 2009.

Clearances by year, as a table
510(k) clearance decisions for Neusoft Positron Medical Systems Co.,Ltd., by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K090178ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8KPSSubstantially Equivalent

Registered establishments

FDA registered establishments for Neusoft Positron Medical Systems Co.,Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30076759503007675950NEUSOFT POSITRON MEDICAL SYSTEMS CO.,LTD.No.177-2, Chuangxin Road, Hunnan District, Shen Yang Liaoning 110167 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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Data as of , FDA export datePage updated Source: openFDA, public domain