GE Vscan Compact Diagnostic Ultrasound System
FDA 510(k) K092756 · Ge Vingmed Ultrasound AS
510(k) numberK092756
Submission
- Device name
- GE Vscan Compact Diagnostic Ultrasound System
- Applicant
- Ge Vingmed Ultrasound AS
Horten, NO - Received
- September 9, 2009
- Decision date
- September 28, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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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| K150085 | GE EchoPACLLZ · Traditional | 03/02/2015SE |
| K141093 | 6VT-D Ultrasound TransducerITX · Traditional | 05/15/2014SE |
| K131685 | GE EchopacLLZ · Traditional | 09/24/2013SE |
| K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYN · Special | 07/12/2013SE |
| K123894 | GE EchopacLLZ · Traditional | 01/29/2013SE |
| K120201 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYO · Traditional | 04/19/2012SE |
| K101149 | GE Vivid E9 Diagnostic Ultrasound Imaging SystemIYO · Special | 10/13/2010SE |
| K101324 | GE Echopac Model BT10LLZ · Traditional | 10/05/2010SE |
| K991842 | System Five/Echopac with Strain Rate ImagingIYO · Traditional | 06/11/1999SE |
Questions and answers
When was GE Vscan Compact Diagnostic Ultrasound System cleared by the FDA?
GE Vscan Compact Diagnostic Ultrasound System (K092756) received a 510(k) decision of Substantially Equivalent on September 28, 2009, 19 days after the submission was received.
What is the product code of K092756?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.