Identity
- Trade Name
- FDR ES II C25 FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging conversion system FDA UDI
- Device Name
- The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications. FDA UDI
- Model / Reference
- DR-ID 1285 SE FF E FDA UDI
- Description
- The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410549300 FDA UDI
- 510(k) Number
- K142003 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Diagnostic x-ray digital imaging conversion system 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: Diagnostic x-ray digital imaging conversion system
Fdr Es Ii C25 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic x-ray digital imaging conversion system.
- FLAATZ — Drtech Corp. · Class II
- FLAATZ — Drtech Corp. · Class II
- 14X17 Portable GOS Flat Panel Detector — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- 4343 CsI Digital Flat Panel Detector — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- 17X17 CsI Fixed Flat Panel Detector — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- FLAATZ — Drtech Corp. · Class II
- 17X17 GOS Fixed Flat Panel Detector — KONICA MINOLTA MEDICAL IMAGING U.S.A., INC. · Class II
- CARESTREAM DRX-1 System Detector — CARESTREAM HEALTH, INC. · Class II
Cleared under the same submission
K142003 also covers:
- D-EVO II C24 — FUJIFILM Corporation
- D-EVO II C24 — FUJIFILM Corporation
- D-EVO II C35 — FUJIFILM Corporation
- D-EVO II C35 — FUJIFILM Corporation
- D-EVO II C43 — FUJIFILM Corporation
- D-EVO II C43 — FUJIFILM Corporation
- D-EVO II G35 — FUJIFILM Corporation
- D-EVO II G35 — FUJIFILM Corporation
- D-EVO II G43 — FUJIFILM Corporation
- D-EVO II G43 — FUJIFILM Corporation
- DR-ID 1200MC — FUJIFILM Corporation
- DR-ID 1200MC — 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 3e690278-b533-4112-bccb-b22952287e50 35 fields · synced Jun 1, 2026