Identity
- Trade Name
- DR-ID 1280PB FDA UDI
- Generic Name
- Diagnostic x-ray digital imaging conversion system FDA UDI
- Device Name
- The DR-ID 1280PB supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit. FDA UDI
- Model / Reference
- DR-ID 1280 PB E FDA UDI
- Description
- The DR-ID 1280PB supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410530643 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
Dr-Id 1280pb 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 4ce86595-d311-4991-834d-6f8b79a34ce8 35 fields · synced Jun 8, 2026