Acuson AL558 Transducer
FDA 510(k) K854785 · Acuson Computed Sonography
510(k) numberK854785
Submission
- Device name
- Acuson AL558 Transducer
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- November 29, 1985
- Decision date
- January 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K893863 | Acuson L538 TransducerITX · Traditional | 05/23/1990SE |
| K874028 | Acuson S328 TransducerIYO · Traditional | 06/21/1988SE |
| K874861 | Acuson S328 Transducer for Cardiac Color Flow App.DPT · Traditional | 05/11/1988SE |
| K874363 | Acuson S228 and S328 Transducers for Abdom. Appli.IYO · Traditional | 05/02/1988SE |
| K874922 | Acuson Transperineal Needle GuideITX · Traditional | 02/19/1988SE |
| K874860 | Acuson I7505 Transducer for Intracavitary Applica.ITX · Traditional | 02/17/1988SE |
| K871506 | Acuson L538 TransducerJOP · Traditional | 09/28/1987SE |
| K871416 | Auxiliary Continuous Wave Doppler TransducerJOP · Traditional | 09/28/1987SE |
| K871239 | Acuson Physiological Control ModuleDPS · Traditional | 06/05/1987SE |
| K864578 | Acuson TV519 TransducerHGL · Traditional | 03/27/1987SE |
Questions and answers
When was Acuson AL558 Transducer cleared by the FDA?
Acuson AL558 Transducer (K854785) received a 510(k) decision of Substantially Equivalent on January 15, 1986, 47 days after the submission was received.
What is the product code of K854785?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.