FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Falcon/Xpress (Falcon/Xpress)
K Number: K242662
·
Decision Dec 18, 2024
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
71
Applicant Total
6
Review Days
105
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Basic Information
- Device Name
- Falcon/Xpress (Falcon/Xpress)
- K Number
- K242662
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2880
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Viasonix , Ltd.
- Date Received
- September 4, 2024
- Decision Date
- December 18, 2024
- Product Code
- JOP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JOP | Transducer, Ultrasonic | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
| K202742 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory | Jan 25, 2021 | Substantially Equivalent |
| K192607 | LiteWalk | Dec 19, 2019 | Substantially Equivalent |
| K191023 | Dolphin/IQ, Dolphin/4D and Dolphin/MAX | May 16, 2019 | Substantially Equivalent |
| K170859 | Dolphin/IQ and Dolphin/4D | Nov 14, 2017 | Substantially Equivalent |
| K111416 | FALCON | Jul 15, 2011 | Substantially Equivalent |