Identity
- Trade Name
- Cysware® 4H FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software. FDA UDI
- Model / Reference
- 1.xx.xxx FDA UDI
- Description
- Abys® Medical Cysware® 4H web platform is a web-based medical device designed and intended for use prior to surgery to gather in one place the information needed by the surgeon to make a surgical planning. As a result, a planning assistance file is created and contains medical imaging, 3d models, documents, and notes. The ABYS® MEDICAL Cysware® 4H web platform is used to export the planning assistance file to the Abys® Medical Cysart® 4H mixed reality application, another medical software. FDA UDI
Identifiers
- Catalog Number
- H001-WEB001 FDA UDI
- Primary DI / UDI-DI
- 03760365550004 FDA UDI
- 510(k) Number
- K221796 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
Cysware® 4H by Abys Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221796 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
- Abys Medical
Sources (1)
- FDA UDI f893435f-33fe-4ffa-a11c-728b1f8fa42c 35 fields · synced Jun 1, 2026