INVISION MEDICAL TECHNOLOGY

FDA Device Registration & Listing · Sunnyvale, CA, US · Registration 3042902406

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042902406
FEI Number
3042902406
Entity Name
INVISION MEDICAL TECHNOLOGY
City/State/Country
Sunnyvale, CA, US
Establishment Address
1497 Samedra St, Sunnyvale, CA 94087, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
InVision Medical Technology (Owner Number: 10094692)
Owner / Operator Contact Address
1497 Samedra Street, Sunnyvale, CA 94087, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232331
PMA Number
N/A

All Registered Proprietary Names

Precision Cardiac Amyloid Precision LVEF

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SDJ Adjunctive Cardiac Amyloidosis Status Indicator Cardiovascular Class 2 870.2200 2025-12-16
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-12-16

Official Correspondent

David Ouyang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InVision Medical Technology
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042902406. Last updated year: 2026. Please use registration number 3042902406 when referencing this establishment in official correspondence.
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