Acuson X300 Diagnostic Ultrasound System
FDA 510(k) K090276 · Siemens Medical Solutions USA, Inc.
510(k) numberK090276
Submission
- Device name
- Acuson X300 Diagnostic Ultrasound System
- Applicant
- Siemens Medical Solutions USA, Inc.
Mountainview, CA, US - Received
- February 4, 2009
- Decision date
- February 19, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
Other 510(k)s with product code DQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K261696 | ACUNAV Luxera 4D ICE CatheterOBJ · Special | 09/10/2026SE |
| K260488 | MULTIX Impact; MULTIX Impact CKPR · Traditional | 08/31/2026SE |
| K253786 | syngo.CT Coronary CockpitQIH · Traditional | 06/25/2026SE |
| K253678 | MAMMOMAT B.brilliant (11372950)MUE · Traditional | 06/18/2026SE |
| K260844 | ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound…IYN · Traditional | 06/16/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | 05/21/2026SE |
| K254184 | syngo Application SoftwareQIH · Traditional | 04/29/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | 04/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | 03/20/2026SE |
Questions and answers
When was Acuson X300 Diagnostic Ultrasound System cleared by the FDA?
Acuson X300 Diagnostic Ultrasound System (K090276) received a 510(k) decision of Substantially Equivalent on February 19, 2009, 15 days after the submission was received.
What is the product code of K090276?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.