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Augmento
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref DeepTek_001Model Augmento
Identity
- Trade Name
- Augmento FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- Augmento EUDAMED
- Model / Reference
- Augmento EUDAMEDDeepTek_001 EUDAMED2.2.65 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908023670007 EUDAMEDFDA UDI
- Basic UDI-DI
- 8908023670DT0012F EUDAMED
- 510(k) Number
- K222781 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Malta 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
Yes
FDA UDI
Augmento by Deeptek Medical Imaging Private Limited — Class I — 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 | K222781 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8908023670DT0012F | Class I | Active |
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Manufacturer
- Manufacturer
- DeepTek Medical Imaging Private Limited
- EUDAMED SRN
- IN-MF-000040297
- Authorised Representative
- Specculo Limited MT-AR-000034988
Sources (3)
- EUDAMED 58a2c05c-43a2-4a77-b88f-8fab2adcc937 61 fields · synced Jun 19, 2026
- FDA UDI cd32ed0d-f0b9-454c-b247-b15b2497b13b 33 fields · synced May 30, 2026
- FDA 510(k) K222781 1 fields · synced May 18, 2026