510(k) K243866
- Device
- InVision Precision Cardiac Amyloid
- Applicant
- InVision Medical Technology Corporation
- 510(k) number
- K243866
- Product code
- SDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-21
- Date received
- 2024-12-17
- Regulation
- 870.2200
- Classification name
- Adjunctive Cardiac Amyloidosis Status Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- David Ouyang
- Address
- 9702 Cisco St. Los Angeles CA US 90034 90034
FDA Registration Numbers#
- 3017425832
- 3042902406
- 3016585383