Identity
- Trade Name
- D-EVOIII C43i FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. FDA UDI
- Model / Reference
- DR-ID 1812 SE NON CE E FDA UDI
- Description
- The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410478648 FDA UDI
- 510(k) Number
- K192932 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Stationary basic diagnostic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary basic diagnostic x-ray system, digital
D-EVOIII C43i by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192932 also covers:
- D-EVOIII C25i — FUJIFILM Corporation
- D-EVOIII C25i — FUJIFILM Corporation
- D-EVOIII C35i — FUJIFILM Corporation
- D-EVOIII C35i — FUJIFILM Corporation
- D-EVOIII C43i — FUJIFILM Corporation
- D-EVOIII G35 — FUJIFILM Corporation
- D-EVOIII G35i — FUJIFILM Corporation
- D-EVOIII G35i — FUJIFILM Corporation
- D-EVOIII G43 — FUJIFILM Corporation
- D-EVOIII G43i — FUJIFILM Corporation
- D-EVOIII G43i — FUJIFILM Corporation
- D-EVOIII G80i — FUJIFILM Corporation
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
- FUJIFILM Corporation
Sources (1)
- FDA UDI 1aba074a-be08-474a-8345-f3a2e4d3b1aa 37 fields · synced May 30, 2026