7.5 MHZ WP Transducer
FDA 510(k) K810748 · General Electric Co.
510(k) numberK810748
Submission
- Device name
- 7.5 MHZ WP Transducer
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- March 20, 1981
- Decision date
- June 19, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code ITX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K110798 | Senographe DS, Senographe EssentialMUE · Traditional | 12/22/2011SE |
| K103485 | Senograph DS, Senograph EssenstialMUE · Traditional | 10/06/2011SE |
| K103489 | GE Veo Reconstruction OptionJAK · Traditional | 09/09/2011SE |
| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was 7.5 MHZ WP Transducer cleared by the FDA?
7.5 MHZ WP Transducer (K810748) received a 510(k) decision of Substantially Equivalent on June 19, 1981, 91 days after the submission was received.
What is the product code of K810748?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.