Interson Endocavity Probe for Atl Ultrasound Syst
FDA 510(k) K911117 · Interson Corp.
510(k) numberK911117
Submission
- Device name
- Interson Endocavity Probe for Atl Ultrasound Syst
- Applicant
- Interson Corp.
Pleasanton, CA, US - Received
- March 7, 1991
- Decision date
- December 17, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code ITX
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|---|---|---|---|
| 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 |
|---|---|---|
| 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 |
| 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 |
| K900555 | Interson Multiplane Rectal Probe for Aloka Ultra.ITX · Traditional | 05/02/1990SE |
| 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 Endocavity Probe for Atl Ultrasound Syst cleared by the FDA?
Interson Endocavity Probe for Atl Ultrasound Syst (K911117) received a 510(k) decision of Substantially Equivalent on December 17, 1991, 285 days after the submission was received.
What is the product code of K911117?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.