Lumify Diagnostic Ultrasound System
FDA 510(k) K192226 · Philips Health Care
510(k) numberK192226
Submission
- Device name
- Lumify Diagnostic Ultrasound System
- Applicant
- Philips Health Care
Bothell, WA, US - Received
- August 16, 2019
- Decision date
- September 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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
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| K201352 | 3D Auto LAALLZ · Traditional | 08/17/2020SE |
| K200974 | QLAB Advanced Quantification SoftwareQIH · Traditional | 06/03/2020SE |
| K200179 | Collaboration LiveLLZ · Traditional | 02/18/2020SE |
| K191647 | QLAB Advanced Quantification SoftwareQIH · Traditional | 12/20/2019SE |
| K190913 | QLAB Advanced Quantification Software 13LLZ · Special | 06/18/2019SE |
| K172607 | Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System…IYN · Traditional | 10/04/2017SE |
| K171314 | QLAB Advanced Quantification SoftwareLLZ · Traditional | 05/30/2017SE |
| K163020 | Xperius Ultrasound SystemIYN · Traditional | 11/16/2016SE |
| K162549 | Lumify Ultrasound SystemIYN · Traditional | 10/03/2016SE |
| K162329 | CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemIYN · Traditional | 09/14/2016SE |
Questions and answers
When was Lumify Diagnostic Ultrasound System cleared by the FDA?
Lumify Diagnostic Ultrasound System (K192226) received a 510(k) decision of Substantially Equivalent on September 6, 2019, 21 days after the submission was received.
What is the product code of K192226?
The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.