Volcano iFR Modality, iFR Scout feature
FDA 510(k) K150441 · Volcano Corporation
510(k) numberK150441
Submission
- Device name
- Volcano iFR Modality, iFR Scout feature
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- February 20, 2015
- Decision date
- March 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code IYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260190 | ArthurIYO · Traditional | ROPCA ApS | 06/18/2026SE |
| K252237 | EdgeFlow UW20IYO · Traditional | Edgecare, Inc. | 04/17/2026SE |
| K254021 | Accuro XVIYO · Traditional | Rivanna Medical, Inc. | 04/09/2026SE |
| K253898 | QT Scanner 2000 Model AIYO · Special | QT Imaging Holdings, Inc. | 03/04/2026SE |
| K253714 | IntraSight PlusIYO · Traditional | Philips Image Guided Therapy Corporation | 02/24/2026SE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 02/06/2026SE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional | DeepSight Technology, Inc. | 08/01/2025SE |
| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K210235 | Verrata PLUS Pressure Guide WireDQX · Special | 04/15/2021SE |
| K203719 | IntraSight MobileIYO · Special | 01/19/2021SE |
| K202543 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Special | 09/28/2020SE |
| K192886 | OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm…DQX · Traditional | 03/26/2020SE |
| K190626 | SyncVision SystemOWB · Traditional | 04/12/2019SE |
| K190078 | IntraSightDSA · Special | 02/11/2019SE |
| K173860 | s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…IYO · Traditional | 04/11/2018SE |
| K172455 | CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…IYO · Special | 10/25/2017SE |
| K172574 | SyncVision SystemOWB · Traditional | 10/05/2017SE |
| K170385 | CORE M2 Vascular SystemIYO · Special | 04/06/2017SE |
Questions and answers
When was Volcano iFR Modality, iFR Scout feature cleared by the FDA?
Volcano iFR Modality, iFR Scout feature (K150441) received a 510(k) decision of Substantially Equivalent on March 20, 2015, 28 days after the submission was received.
What is the product code of K150441?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.