Intra-Operative Ultrasound Transducer
FDA 510(k) K140854 · Hitachi Aloka Medical, Ltd.
510(k) numberK140854
Submission
- Device name
- Intra-Operative Ultrasound Transducer
- Applicant
- Hitachi Aloka Medical, Ltd.
Wallingford, CT, US - Received
- April 3, 2014
- Decision date
- June 11, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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| K142368 | Noblus Diagnostic Ultrasound ScannerIYN · Traditional | 01/14/2015SE |
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| K130308 | Noblus Ultrasound Diagnostic SystemIYN · Special | 04/05/2013SE |
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Questions and answers
When was Intra-Operative Ultrasound Transducer cleared by the FDA?
Intra-Operative Ultrasound Transducer (K140854) received a 510(k) decision of Substantially Equivalent on June 11, 2014, 69 days after the submission was received.
What is the product code of K140854?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.