Acuson L382 and L312 Transducers
FDA 510(k) K861866 · Acuson Computed Sonography
510(k) numberK861866
Submission
- Device name
- Acuson L382 and L312 Transducers
- Applicant
- Acuson Computed Sonography
Mountain View, CA, US - Received
- May 13, 1986
- Decision date
- July 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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| K233976 | VasoGuard (V10, V8, V6, V4, V2)JOP · Traditional | Corvascular Diagnostics, LLC | 07/19/2024SE |
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| K111416 | FalconJOP · Traditional | Viasonix , Ltd. | 07/15/2011SE |
| K071730 | Studiodop VicorderJOP · Abbreviated | Skidmore Medical, Limited | 12/20/2007SE |
| K010482 | Echoflow Portable Doppler Blood Flow Measurement System; Model PEF-1JOP · Special | Echocath, Inc. | 03/20/2001SE |
| K002766 | Nicolet VasoguardJOP · Abbreviated | Nicolet Biomedical | 11/30/2000SE |
| K990642 | Echoflow Doppler Blood Velocity MeterJOP · Traditional | Echocath, Inc. | 09/16/1999SE |
More from Echocath, Inc.
| 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 L382 and L312 Transducers cleared by the FDA?
Acuson L382 and L312 Transducers (K861866) received a 510(k) decision of Substantially Equivalent on July 18, 1986, 66 days after the submission was received.
What is the product code of K861866?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.