SyncVision Medical Image Processing System 400-0100.10
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- SyncVision Medical Image Processing System EUDAMEDSyncVision System FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- SyncVision EUDAMED
- Model / Reference
- 400-0100.10 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 400-0100.10 FDA UDI
- Primary DI / UDI-DI
- 00845225012434 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225012434 EUDAMED
- FDA Product Code
- OWB FDA UDI
- EMDN Code
- C010499 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - OTHER EUDAMED
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The SyncVision Medical Image Processing System is a Class IIa medical imaging device (Nomenclature Code: C010499) designed for processing fluoroscopic images. It provides quantitative analysis of arterial dimensions and enhances visualization of stent deployment regions during interventional cardiology procedures.
This system is used in catheterization labs for real-time in-procedure imaging and offline post-procedural analysis. It is non-sterile, non-reusable, and non-implantable, with no latex components. The device carries FDA 510(k) and MDD authorizations, and its UDI is B-00845225012434. It operates as an active medical device with measuring functionality.
Frequently asked questions
What is the SyncVision Medical Image Processing System primarily used for in clinical settings?
The SyncVision Medical Image Processing System is designed for processing fluoroscopic images during interventional cardiology procedures. It provides real-time quantitative analysis of arterial dimensions and enhances visualization of stent deployment regions, helping clinicians monitor and assess outcomes during catheterization lab interventions.
Is the SyncVision system reusable, and if not, how is it intended to be used?
The SyncVision system is explicitly labeled as non-reusable, meaning it is intended for single-use only. Since it is non-sterile and non-implantable, it is meant to be used once per procedure and then disposed of, ensuring compliance with infection control protocols.
What regulatory pathways has the SyncVision Medical Image Processing System undergone, and who is the manufacturer?
The SyncVision system has received FDA 510(k) clearance and MDD (Medical Device Directive) authorization, confirming its compliance with both U.S. and European regulatory standards. The manufacturer is Volcano Corporation, based in the United States, with Volcano Europe handling authorized representation in applicable markets.
Does the SyncVision system include any measuring functionality, and what type of device classification does it fall under?
Yes, the SyncVision system is classified as an active medical device with measuring functionality, enabling precise quantitative analysis of arterial dimensions during procedures. It is categorized as a Class IIa device under the nomenclature code C010499, indicating a moderate risk level requiring regulatory oversight.
How should the SyncVision system be stored, and are there any special considerations for its handling?
While the provided data does not specify storage conditions explicitly, the system is non-sterile and non-reusable, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is intended for single-use, ensure proper inventory management to avoid accidental reuse, and follow manufacturer guidelines for setup and maintenance to preserve functionality.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., Volcano SyncVision System Medical Image Processing, Philips Volcano - SyncVision Precision guidance system
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172574 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K161756 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K151904 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K190626 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00845225012434 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
- EUDAMED SRN
- US-MF-000020094
- Authorised Representative
- Volcano Europe BE-AR-000000929
Sources (3)
- EUDAMED 3013ea50-d595-4d07-b80f-580d7108ae53 61 fields · synced Sep 18, 2026
- FDA UDI 00fd3e7f-80c0-4498-8221-5b37794cf6fb 35 fields · synced May 30, 2026
- FDA 510(k) K172574 1 fields · synced May 18, 2026