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

Gangseo-gu Seoul, KR

ALPINION MEDICAL SYSTEMS CO., LTD. appears in FDA device records in Gangseo-gu Seoul, KR. FDA records list 26 510(k) clearances between and , no PMA records and 2 registered establishments. 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
26
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 26 510(k) clearances for ALPINION MEDICAL SYSTEMS Co., Ltd. between 2011 and 2023. The busiest year on record is 2012, with 5. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for ALPINION MEDICAL SYSTEMS Co., Ltd., by decision year
YearClearances
20111
20125
20132
20142
20151
20162
20171
20183
20191
20202
20212
20223
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223564X-CUBE 50, X-CUBE 60IYNSubstantially Equivalent
K221093X-CUBE 70, X-CUBE 90IYNSubstantially Equivalent
K220857X-CUBE 50, X-CUBE 60IYNSubstantially Equivalent
K213523X-CUBE i8, X-CUBE i9IYNSubstantially Equivalent
K211300X-CUBE 90IYNSubstantially Equivalent
K211299X-CUBE 70IYNSubstantially Equivalent
K200450X-Cube 70IYNSubstantially Equivalent
K200449X-Cube 90IYNSubstantially Equivalent
K182594E-CUBE i7IYNSubstantially Equivalent
K182845minisonoIYNSubstantially Equivalent
K181617E-CUBE 8IYNSubstantially Equivalent
K181277E-CUBE 12IYNSubstantially Equivalent
K172732E-CUBE 8IYNSubstantially Equivalent
K161439E-CUBE 11IYNSubstantially Equivalent
K153424E-CUBE i7IYNSubstantially Equivalent
K150773E-CUBE 15 Diagnostic Ultrasound SystemIYNSubstantially Equivalent
K142884E-CUBE 12IYNSubstantially Equivalent
K142733E-CUBE 5IYNSubstantially Equivalent
K132687E-CUBE 7IYNSubstantially Equivalent
K123610E-CUBE 15IYNSubstantially Equivalent
K123611E-CUBE 7IYNSubstantially Equivalent
K121729E-CUBE 7IYNSubstantially Equivalent
K121937E-CUBE INNOIYNSubstantially Equivalent
K121888E-CUBE 15IYOSubstantially Equivalent
K120060E-CUBE 9IYNSubstantially Equivalent
K111864E-CUBE 9IYNSubstantially Equivalent

Registered establishments

FDA registered establishments for ALPINION MEDICAL SYSTEMS Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30248389223024838922ALPINION MEDICAL SYSTEMS CO., LTD.4F, 16, Simin-daero 327beon-gil, Dongan-gu, Anyang-si Gyeonggi 14055 KR2026
30089501273008950127ALPINION MEDICAL SYSTEMS Co., Ltd.4F, 15, Magokjungang 14-ro, Gangseo-gu Seoul 07789 KR2026

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