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Optical Coherence Tomography OCT-A1
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref BT8-1835Model Optical Coherence Tomography
by Canon Inc.
Identity
- Trade Name
- Optical Coherence Tomography OCT-A1 EUDAMEDCANON INC. FDA UDI
- Generic Name
- Retinal optical coherence tomography system FDA UDI
- Device Name
- OCT-R1 EUDAMED
- Model / Reference
- Optical Coherence Tomography EUDAMEDBT8-1835 EUDAMEDOCT-A1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04549292147216 EUDAMEDFDA UDI
- Basic UDI-DI
- 4549292oc01CW EUDAMED
- 510(k) Number
- K182942 FDA UDI
- FDA Product Code
- HLI FDA UDI
- EMDN Code
- Z12120113 OPHTHALMOMETERS EUDAMED
- GMDN Term
- Retinal optical coherence tomography system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Optical Coherence Tomography OCT-A1 by Canon 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 | K182942 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4549292oc01CW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Canon Inc.
- EUDAMED SRN
- JP-MF-000013254
- Authorised Representative
- Canon Medical Systems Europe B.V. NL-AR-000010531
Sources (3)
- EUDAMED b0b20d08-eae6-4dd0-9dfa-7418d0dcfd96 61 fields · synced Jul 29, 2026
- FDA UDI aaace8ec-2bdc-4604-97f5-44e26c100b7f 33 fields · synced May 30, 2026
- FDA 510(k) K182942 1 fields · synced May 18, 2026