Identity
- Trade Name
- FDR ES G43 FDA UDI
- Generic Name
- Stationary basic diagnostic x-ray system, digital FDA UDI
- Device Name
- The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications. FDA UDI
- Model / Reference
- DR-ID 1272 SE E FDA UDI
- Description
- The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410361353 FDA UDI
- 510(k) Number
- K142003 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
Fdr Es G43 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 684bb6d8-2b81-4226-98f9-5239594e324e 37 fields · synced May 30, 2026