EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
FDA 510(k) K253595 · Philips Ultrasound, LLC
510(k) numberK253595
Submission
- Device name
- EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, LLC
Bothell, WA, US - Received
- November 18, 2025
- Decision date
- March 27, 2026
- 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 |
|---|---|---|
| K262311 | Alturion Series Diagnostic Ultrasound SystemIYN · Special | 08/04/2026SE |
| K261211 | Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional | 07/27/2026SE |
| K260667 | Alturion Series Diagnostic Ultrasound SystemIYN · Traditional | 06/29/2026SE |
| K260680 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | 05/27/2026SE |
| K260123 | EPIQ Series Diagnostic Ultrasound SystemIYN · Traditional | 05/27/2026SE |
| K252558 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | 05/05/2026SE |
| K252557 | Lumify Diagnostic Ultrasound SystemIYN · Traditional | 12/22/2025SE |
| K251651 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Special | 10/09/2025SE |
| K251455 | EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemIYN · Special | 07/24/2025SE |
| K250886 | EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound SystemsIYN · Special | 06/18/2025SE |
Questions and answers
When was EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System cleared by the FDA?
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System (K253595) received a 510(k) decision of Substantially Equivalent on March 27, 2026, 129 days after the submission was received.
What is the product code of K253595?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.