FDA 510(k) ClearanceIYN
Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
FDA 510(k) K261211 · Philips Ultrasound, LLC
Clearance details
Ask AI- 510(k) number
- K261211
- Device name
- Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, LLC
- Product code
- IYN
- Decision
- Substantially Equivalent
- Decision date
- Device class
- Class 2
- Regulation number
- 892.1550
- Advisory committee
- RA
- Medical specialty
- Radiology
Candidate predicate devices
Ask AIOther devices cleared under product code IYN form a screening cohort, not a predicate determination. Compare intended use, technological characteristics, performance evidence, labeling, and current legal-marketing status before selecting a predicate.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261933 | Voluson Expert 18; Voluson Expert 20; Voluson Expert 22 | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | |
| K262548 | EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K263182 | EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | |
| K261313 | Vivid Explorer/Vivid Advanced/Vivid Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | |
| K254027 | Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90) | Sonoscape Medical Corp. | |
| K261668 | Venue Go | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | |
| K262311 | Alturion Series Diagnostic Ultrasound System | Philips Ultrasound, LLC | |
| K261288 | Handheld Ultrasound Scanner | IMGFAX CO., LTD. | |
| K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | |
| K261412 | V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; | Samsung Medison Co., Ltd. | |
| K261081 | Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) | Beijing Konted Medical Technology Co.,Ltd |
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