The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Hs50 / Hs60 Diagnostic Ultrasound System.
| Device ID | K170493 |
| 510k Number | K170493 |
| Device Name: | HS50 / HS60 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Samsung Medison Co., Ltd. 42, Teheran-ro 108-gil, Gangnam-gu Seoul, KR |
| Contact | Jiyeon Cho |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2017-02-17 |
| Decision Date | 2017-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167764548 | K170493 | 000 |
| 08809702986344 | K170493 | 000 |
| 08809702986450 | K170493 | 000 |
| 08809702986771 | K170493 | 000 |
| 08809702986818 | K170493 | 000 |
| 08809702981820 | K170493 | 000 |
| 08809702985576 | K170493 | 000 |
| 08809702985859 | K170493 | 000 |
| 08806167759179 | K170493 | 000 |
| 08806167759674 | K170493 | 000 |
| 08806167759698 | K170493 | 000 |
| 08806167797829 | K170493 | 000 |