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Second Opinion
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref SECONDOPINION2
by Pearl Inc.
Identity
- Trade Name
- Second Opinion FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Second Opinion EUDAMED
- Model / Reference
- SECONDOPINION2 EUDAMED2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860003567920 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D087SECONDOPINION2H8 EUDAMED
- 510(k) Number
- K210365 FDA UDI
- FDA Product Code
- MYN FDA UDI
- EMDN Code
- Z11030392 INSTRUMENTS FOR EXTRAORAL DENTAL RADIOLOGY - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2070 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Second Opinion by Pearl, Inc. — 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 | K210365 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++D087SECONDOPINION2H8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Pearl Inc.
- EUDAMED SRN
- US-MF-000026473
- Authorised Representative
- ALPA Medical IT-AR-000007276
Sources (3)
- EUDAMED 28db6a4b-72b7-46ed-8de9-7cfaf956b7e0 61 fields · synced Aug 1, 2026
- FDA UDI b2298fa4-0f11-4853-93e8-ad107d47bc09 33 fields · synced May 30, 2026
- FDA 510(k) K210365 1 fields · synced May 18, 2026