6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
FDA 510(k) K241671 · Esaote, S.p.A.
510(k) numberK241671
Submission
- Device name
- 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
- Applicant
- Esaote, S.p.A.
Genoa, IT - Received
- June 11, 2024
- Decision date
- May 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261313 | Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 09/02/2026SE |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional | Sonoscape Medical Corp. | 08/24/2026SE |
| K261668 | Venue GoIYN · Traditional | GE Medical Systems Ultrasound and Primary care… | 08/07/2026SE |
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | Philips Ultrasound, LLC | 08/04/2026SE |
| K261835 | LOGIQ FocusIYN · Traditional | GE Medical Systems Ultrasound and Primary Care… | 07/30/2026SE |
| K261288 | Handheld Ultrasound ScannerIYN · Traditional | Imgfax Co., Ltd. | 07/30/2026SE |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | Samsung Medison Co., Ltd. | 07/28/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | Philips Ultrasound, LLC | 07/27/2026SE |
| K261272 | ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional | Esonic Technology (Wuhan) Co., Ltd. | 07/23/2026SE |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special | Beijing Konted Medical Technology Co.,Ltd | 07/23/2026SE |
More from Beijing Konted Medical Technology Co.,Ltd
| 510(k) | Device | Decision |
|---|---|---|
| K261331 | I-Genius (100019400)LNH · Traditional | 07/31/2026SE |
| K253288 | 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)IYN · Traditional | 04/06/2026SE |
| K260746 | S-scan Open (100001800)LNH · Special | 03/27/2026SE |
| K251901 | Magnifico Open (100009900)LNH · Traditional | 03/05/2026SE |
| K253310 | 7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)IYN · Special | 11/25/2025SE |
| K243253 | 6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)IYN · Traditional | 06/18/2025SE |
| K241133 | Magnifico Open (100009900); Magnifico MSK ( 100009910)LNH · Special | 06/26/2024SE |
| K230179 | 6440 MyLabX90IYN · Traditional | 11/29/2023SE |
| K212419 | Magnifico Open, Magnifico MSKLNH · Traditional | 02/04/2022SE |
| K212021 | 6430 MyLabX75, 6430 MyLab XPro75IYN · Traditional | 09/16/2021SE |
Questions and answers
When was 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) cleared by the FDA?
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) (K241671) received a 510(k) decision of Substantially Equivalent on May 16, 2025, 339 days after the submission was received.
What is the product code of K241671?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.