Identity
- Trade Name
- PACS Scan CD FDA UDI
- Generic Name
- Radiography digital imaging scanner FDA UDI
- Device Name
- PACS Scan Software CD FDA UDI
- Model / Reference
- 5 FDA UDI
- Description
- PACS Scan Software CD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850677007112 FDA UDI
- 510(k) Number
- K083618 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiography digital imaging scanner
PACS Scan CD by Hyland Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ScanX Swift Digital Imaging System — Air Techniques, Inc. · Class II
- FireCR — DIGIRAY Corp. · Class II
Cleared under the same submission
K083618 also covers:
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 |
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Manufacturer
- Manufacturer
- Hyland Llc
Sources (1)
- FDA UDI 99dfe519-6c8e-4ab2-a111-34c52a5828d9 34 fields · synced May 31, 2026