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CORE Series Precision Guided Therapy System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CORE Series Precision Guided Therapy System FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Model / Reference
- S18081AA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00845225012670 FDA UDI
- 510(k) Number
- K113486 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiovascular ultrasound imaging system
CORE Series Precision Guided Therapy System by Volcano Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiovascular ultrasound imaging system.
- Vivid — GE Medical Systems (China) Co., Ltd. · Class II
- iLab™ — Boston Scientific · Class II
- SLT IVUS P1 Display Unit — Provisio Medical, Inc. · Class II
- iLab Ultrasound Imaging System — Boston Scientific · Class II
- iLab Ultrasound Imaging System — Boston Scientific · Class II
- AVVIGO™+ — Boston Scientific · Class II
- Medistim System Activation Card — Medi-Stim Asa · Class II
- AVVIGO™+ — Boston Scientific · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (2)
- FDA UDI a0ab2490-f78c-4a5b-9fb3-8b6e9f4feadc 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026