Volusion Small Parts Transducer, Model S-Vnw 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7
FDA 510(k) K992155 · Medison America, Inc.
510(k) numberK992155
Submission
- Device name
- Volusion Small Parts Transducer, Model S-Vnw 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7
- Applicant
- Medison America, Inc.
Pleasanton, CA, US - Received
- June 25, 1999
- Decision date
- July 8, 1999
- 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 |
|---|---|---|
| K032329 | SA 9900 Plus Diagnostic Ultrasound SystemIYN · Traditional | 08/06/2003SE |
| K031552 | Mycolor 202 Diagnostic Ultrasound System and TransducersIYN · Traditional | 05/30/2003SE |
| K013627 | Sonoace SA-8000 Diagnostic Ultrasound SystemIYN · Traditional | 11/16/2001SE |
| K012887 | SA6000II Diagnostic Ultrasound SystemIYO · Traditional | 09/12/2001SE |
| K012867 | Sonoace 9900 Diagnostic Ultrasound SystemIYN · Traditional | 09/12/2001SE |
| K003525 | Voluson 730 Diagnostic Ultrasound SystemIYN · Traditional | 11/22/2000SE |
| K003121 | Mysono 201 Diagnostic Ultrasound and TransducersIYO · Traditional | 10/20/2000SE |
| K002185 | Sonoace SA 9900 Diagnostic Ultrasound SystemIYN · Traditional | 08/01/2000SE |
| K000030 | Sonoace 600 Diagnostic Ultrasound SystemIYO · Traditional | 01/19/2000SE |
| K993517 | Combison 530D/VOLUSON 530D, Tissue Harmonic Imaging (Thi) OptionIYO · Traditional | 11/02/1999SE |
Questions and answers
When was Volusion Small Parts Transducer, Model S-Vnw 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7 cleared by the FDA?
Volusion Small Parts Transducer, Model S-Vnw 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7 (K992155) received a 510(k) decision of Substantially Equivalent on July 8, 1999, 13 days after the submission was received.
What is the product code of K992155?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.