CX50 Diagnostic Ultrasound System
FDA 510(k) K081802 · Philips Ultrasound, Inc.
510(k) numberK081802
Submission
- Device name
- CX50 Diagnostic Ultrasound System
- Applicant
- Philips Ultrasound, Inc.
Bothell, WA, US - Received
- June 26, 2008
- Decision date
- July 11, 2008
- 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 ITX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
| K254143 | EM-TECH Passive Ultrasound Probe StrapITX · Traditional | EM-TECH Solutions, Inc. | 08/10/2026SE |
| K260161 | SmartGuide Disposable Guides and GridsITX · Traditional | UC-CARE , Ltd. | 07/30/2026SE |
| K262474 | ND Needle Guidance SystemITX · Traditional | Accurate Access, LLC | 07/27/2026SE |
| K261014 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)ITX · Traditional | Olympus Medical Systems Corporation | 09/18/2025SE |
| K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)ITX · Traditional | Olympus Medical Systems Corporation | 07/11/2025SE |
| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
More from Vitrolife Sweden AB
| 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 |
| K253595 | EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYN · Traditional | 03/27/2026SE |
| 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 |
Questions and answers
When was CX50 Diagnostic Ultrasound System cleared by the FDA?
CX50 Diagnostic Ultrasound System (K081802) received a 510(k) decision of Substantially Equivalent on July 11, 2008, 15 days after the submission was received.
What is the product code of K081802?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.