Identity
- Trade Name
- AVIEW LCS FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Model / Reference
- 1.1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800025300084 FDA UDI
- 510(k) Number
- K201710 FDA UDI
- FDA Product Code
- LLZ FDA UDIJAK FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI892.1750 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiological PACS software
Aview Lcs by Coreline Soft Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological PACS software.
- ThinkingNet — THINKING SYSTEMS CORP. · Class II
- IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
- EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
- QuantX — Qlarity Imaging · Class II
- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
- IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coreline Soft Co., Ltd.
Sources (1)
- FDA UDI 1752ba04-acc9-4033-b64b-87b2f7590d8e 33 fields · synced May 31, 2026