← Back to catalogue
Opensight
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1.8804Model OPENSIGHT510(k) K172418
Identity
- Trade Name
- OPENSIGHT EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- OPENSIGHT EUDAMEDOpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. FDA UDI
- Model / Reference
- OPENSIGHT EUDAMED1.8804 EUDAMEDOpenSight 1.8804 FDA UDI
- Description
- OpenSight is the combination of augmented reality glasses and Novarad's medical imaging software to create three-dimensional holograms of scanned images from different modalities including CR, DX, CT, MR, and PT. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B109OPENSIGHT188040 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B109OPENSIGHTG3 EUDAMED
- Direct Marketing DI
- B109OPENSIGHT188040 EUDAMED
- 510(k) Number
- K172418 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Opensight by Novarad Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172418 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B109OPENSIGHTG3 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novarad Corporation
- EUDAMED SRN
- US-MF-000028327
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED c30ddbb7-b5f5-46c9-96dd-79c0919f8d2a 85 fields · synced Jun 18, 2026
- FDA UDI bb2215af-a5e7-42f0-b2e8-761b7b8ddb4e 35 fields · synced May 30, 2026
- FDA 510(k) K172418 1 fields · synced May 18, 2026