Acuson Radiology Doppler Accessory
FDA 510(k) K852974 · Acuson Computed Sonography
510(k) numberK852974
Submission
- Device name
- Acuson Radiology Doppler Accessory
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- July 15, 1985
- Decision date
- October 24, 1985
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 Radiology Doppler Accessory cleared by the FDA?
Acuson Radiology Doppler Accessory (K852974) received a 510(k) decision of Substantially Equivalent for Some Indications on October 24, 1985, 101 days after the submission was received.
What is the product code of K852974?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.