Acuson I5100 Ultrasound Transducer
FDA 510(k) K884632 · Acuson Corp.
510(k) numberK884632
Submission
- Device name
- Acuson I5100 Ultrasound Transducer
- Applicant
- Acuson Corp.
Mountain View, CA, US - Received
- November 7, 1988
- Decision date
- January 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IYO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253452 | Accuro 3SIYO · Traditional | Rivanna Medical, Inc. | 07/24/2026SE |
| K260190 | ArthurIYO · Traditional | ROPCA ApS | 06/18/2026SE |
| K252237 | EdgeFlow UW20IYO · Traditional | Edgecare, Inc. | 04/17/2026SE |
| K254021 | Accuro XVIYO · Traditional | Rivanna Medical, Inc. | 04/09/2026SE |
| K253898 | QT Scanner 2000 Model AIYO · Special | QT Imaging Holdings, Inc. | 03/04/2026SE |
| K253714 | IntraSight PlusIYO · Traditional | Philips Image Guided Therapy Corporation | 02/24/2026SE |
| K253221 | Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)IYO · Traditional | Eieling Technology (Shenzhen) Limited | 02/06/2026SE |
| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
| K250381 | Deepsight NeedleVue LC1 Ultrasound SystemIYO · Traditional | DeepSight Technology, Inc. | 08/01/2025SE |
| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K023772 | Kinetdx Picture Archiving and Communications SystemLLZ · Traditional | 11/22/2002SE |
| K022896 | CSV12 Software ViewerLLZ · Special | 10/03/2002SE |
| K022567 | Sequoia Signature II Diagnostic Ultrasound SystemIYN · Traditional | 08/13/2002SE |
| K021497 | Cypress Ultrasound SystemIYN · Special | 07/09/2002SE |
| K010950 | Cypress SystemIYO · Abbreviated | 06/27/2001SE |
| K002807 | 3D Organ Assessment W/ Magnetic Position SensingIYO · Traditional | 12/01/2000SE |
| K992631 | Acunav Diagnostic Ultrasound CatheterDQO · Traditional | 12/15/1999SE |
| K992580 | Fetal Assessment CapIYO · Traditional | 10/18/1999SE |
| K991805 | Aspen Ultrasound with Freestyle Imaging OptionIYN · Traditional | 08/02/1999SE |
| K973767 | Harmonic Imaging with ContrastIYO · Traditional | 12/23/1997SE |
Questions and answers
When was Acuson I5100 Ultrasound Transducer cleared by the FDA?
Acuson I5100 Ultrasound Transducer (K884632) received a 510(k) decision of Substantially Equivalent on January 13, 1989, 67 days after the submission was received.
What is the product code of K884632?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.