The following data is part of a premarket notification filed by Fcu Co., Ltd. with the FDA for Sc1 Handheld Ultrasound Imaging System (model: Sc1).
| Device ID | K210468 |
| 510k Number | K210468 |
| Device Name: | SC1 Handheld Ultrasound Imaging System (Model: SC1) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | FCU Co., Ltd. B-620/621, Biz Center, 17, Techno 4-ro Yuseong-gu, KR 34013 |
| Contact | Lee Hee Yeon |
| Correspondent | Lee Hee Yeon FCU Co., Ltd. B-620/621, Biz Center, 17, Techno 4-ro Yuseong-gu, KR 34013 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-16 |
| Decision Date | 2021-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800076600126 | K210468 | 000 |
| 08800076600133 | K210468 | 000 |
| 08800076600140 | K210468 | 000 |
| 08800076600157 | K210468 | 000 |
| 08800076600010 | K210468 | 000 |
| 08800076600027 | K210468 | 000 |
| 08800076600034 | K210468 | 000 |
| 08800076600041 | K210468 | 000 |
| 08800076600058 | K210468 | 000 |
| 08800076600065 | K210468 | 000 |
| 08800076600072 | K210468 | 000 |
| 08800076600089 | K210468 | 000 |
| 08800076600096 | K210468 | 000 |
| 08800076600102 | K210468 | 000 |
| 08800076600119 | K210468 | 000 |