Acuson S328 Transducer
FDA 510(k) K874028 · Acuson Computed Sonography
510(k) numberK874028
Submission
- Device name
- Acuson S328 Transducer
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- October 2, 1987
- Decision date
- June 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K893863 | Acuson L538 TransducerITX · Traditional | 05/23/1990SE |
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| 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 |
| K863236 | Acuson S519B Transducer · Traditional | 02/13/1987SE |
Questions and answers
When was Acuson S328 Transducer cleared by the FDA?
Acuson S328 Transducer (K874028) received a 510(k) decision of Substantially Equivalent on June 21, 1988, 263 days after the submission was received.
What is the product code of K874028?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.