Identity
- Trade Name
- IntraSight Mobile System EUDAMEDFDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Device Name
- IntraSight Mobile EUDAMED
- Model / Reference
- 797415 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 797415 FDA UDI
- Primary DI / UDI-DI
- 00845225012915 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00845225012915 EUDAMED
- 510(k) Number
- K203719 FDA UDI
- FDA Product Code
- IYO FDA UDIDSA FDA UDIDSK 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
- 892.1560 FDA UDI870.2900 FDA UDI870.1110 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
IntraSight Mobile System by Volcano Corporation — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190078 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K203719 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00845225012915 | 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 e9363706-6bf8-44d3-8a88-b1e3b37be62f 61 fields · synced Jul 9, 2026
- FDA UDI a7f1f69d-244a-4cab-9925-296ffa6b4c25 35 fields · synced May 30, 2026
- FDA 510(k) K190078 1 fields · synced May 18, 2026