Interson Multiplane Rectal Probe for Aloka Ultra.
FDA 510(k) K900555 · Interson Corp.
510(k) numberK900555
Submission
- Device name
- Interson Multiplane Rectal Probe for Aloka Ultra.
- Applicant
- Interson Corp.
Pleasanton, CA, US - Received
- February 6, 1990
- Decision date
- May 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K233734 | Interson USB Ultrasound SystemIYN · Special | 12/22/2023SE |
| K163443 | Interson USB Ultrasound SystemIYN · Traditional | 04/13/2017SE |
| K911116 | Interson Endocavity Probe/Kontron Ultrasound SystITX · Traditional | 12/20/1991SE |
| K911117 | Interson Endocavity Probe for Atl Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911115 | Interson Transrectal Probe/Atl Ultrasound SystemITX · Traditional | 12/17/1991SE |
| K911113 | Interson Transrectal Probe/Kontron Ultrasound SystITX · Traditional | 12/17/1991SE |
| K911114 | Interson Endocavity Probe/Aloka Ultrasound SystemITX · Traditional | 11/19/1991SE |
| K911464 | Interson Disposable Biopsy NeedleIYO · Traditional | 09/27/1991SE |
| K896680 | Probe Sheath for Adms & Capistrano Labs Transrec.FED · Traditional | 02/14/1990SE |
| K895725 | Biopsy Needle Guide for Adms Ultrasound ProbesFCG · Traditional | 11/06/1989SE |
Questions and answers
When was Interson Multiplane Rectal Probe for Aloka Ultra. cleared by the FDA?
Interson Multiplane Rectal Probe for Aloka Ultra. (K900555) received a 510(k) decision of Substantially Equivalent on May 2, 1990, 85 days after the submission was received.
What is the product code of K900555?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.