The following data is part of a premarket notification filed by Alpinion Medical Systems Co., Ltd with the FDA for E-cube 15 Diagnostic Ultrasound System.
| Device ID | K150773 |
| 510k Number | K150773 |
| Device Name: | E-CUBE 15 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU Seoul, KR 152-848 |
| Contact | Donghwan Kim |
| Correspondent | Donghwan Kim ALPINION MEDICAL SYSTEMS CO., LTD 1, 6 AND 7FL, VERDI TOWER 72, DIGITAL-RO(ST) 26-GIL(RD) GURO-GU Seoul, KR 152-848 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800013519023 | K150773 | 000 |
| 08800013512048 | K150773 | 000 |
| 08800013512031 | K150773 | 000 |
| 08800013512017 | K150773 | 000 |
| 08800013511089 | K150773 | 000 |
| 08800013511065 | K150773 | 000 |
| 08800013511058 | K150773 | 000 |
| 08800013511041 | K150773 | 000 |
| 08800013511027 | K150773 | 000 |
| 08800013510136 | K150773 | 000 |
| 08800013510099 | K150773 | 000 |
| 08800013510068 | K150773 | 000 |
| 08800013510020 | K150773 | 000 |
| 08800013512055 | K150773 | 000 |
| 08800013513021 | K150773 | 000 |
| 08800013519016 | K150773 | 000 |
| 08800013515001 | K150773 | 000 |
| 08800013510150 | K150773 | 000 |
| 08800013510075 | K150773 | 000 |
| 08800013525000 | K150773 | 000 |
| 08800013519009 | K150773 | 000 |
| 08800013514028 | K150773 | 000 |
| 08800013514004 | K150773 | 000 |
| 08800013513106 | K150773 | 000 |
| 08800013513090 | K150773 | 000 |
| 08800013513069 | K150773 | 000 |
| 08800013513052 | K150773 | 000 |
| 08800013510013 | K150773 | 000 |