RS85 Diagnostic Ultrasound System
FDA 510(k) K240516 · Samsung Medison Co., Ltd.
510(k) numberK240516
Submission
- Device name
- RS85 Diagnostic Ultrasound System
- Applicant
- Samsung Medison Co., Ltd.
Hongcheon-Gun, KR - Received
- February 23, 2024
- Decision date
- June 12, 2024
- 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 |
|---|---|---|
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional | 07/28/2026SE |
| K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…IYN · Traditional | 03/27/2026SE |
| K252018 | HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s…IYN · Traditional | 01/05/2026SE |
| K250999 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…IYN · Traditional | 07/18/2025SE |
| K243702 | V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic…IYN · Traditional | 02/12/2025SE |
| K242511 | V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic…IYN · Traditional | 12/10/2024SE |
| K242444 | HERA W10 Diagnostic Ultrasound System; HERA W9 Diagnostic Ultrasound SystemIYN · Traditional | 11/27/2024SE |
| K241971 | HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound SystemIYN · Traditional | 10/11/2024SE |
| K241302 | SonoSyncLLZ · Traditional | 08/23/2024SE |
| K240631 | V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound SystemIYN · Traditional | 06/21/2024SE |
Questions and answers
When was RS85 Diagnostic Ultrasound System cleared by the FDA?
RS85 Diagnostic Ultrasound System (K240516) received a 510(k) decision of Substantially Equivalent on June 12, 2024, 110 days after the submission was received.
What is the product code of K240516?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.