510(k) K243937
- Device
- Accuro 3S
- Applicant
- Rivanna Medical, Inc.
- 510(k) number
- K243937
- Product code
- IYO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-23
- Date received
- 2024-12-20
- Regulation
- 892.1560
- Classification name
- System, Imaging, Pulsed Echo, Ultrasonic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- F. William Mauldin
- Address
- 2400 Hunters Way Charlottesville VA US 22911 22911
FDA Registration Numbers
- 3002808148
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Source Documents
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