Identity
- Trade Name
- Radlink CR Pro 2200 FDA UDI
- Generic Name
- Computed radiography digital imaging scanner FDA UDI
- Device Name
- The Radlink CR Pro system is a computed radiography system designed for all primary diagnostic radiology applications. It is fully automatic and accepts a variety of cassette sizes.The 16-bit sealed fiber-optic laser technology allows images to be erased after each use, prolonging cassette life. The system includes the Radlink PACS that is DICOM compatible with any other PACS/EMR brand. The software provides image quality control and post-processing functions and enables distribution and routing of DICOM images throughout a healthcare network. Existing patient information can be queried by syncing to any EMR/HIS/RIS modality worklist. FDA UDI
- Model / Reference
- CR201-1 FDA UDI
- Description
- The Radlink CR Pro system is a computed radiography system designed for all primary diagnostic radiology applications. It is fully automatic and accepts a variety of cassette sizes.The 16-bit sealed fiber-optic laser technology allows images to be erased after each use, prolonging cassette life. The system includes the Radlink PACS that is DICOM compatible with any other PACS/EMR brand. The software provides image quality control and post-processing functions and enables distribution and routing of DICOM images throughout a healthcare network. Existing patient information can be queried by syncing to any EMR/HIS/RIS modality worklist. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866389000150 FDA UDI
- 510(k) Number
- K052938 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Computed radiography digital imaging scanner 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Computed radiography digital imaging scanner
Radlink CR Pro 2200 by Radlink, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Computed radiography digital imaging scanner.
- FUJI IMAGING PLATE — FUJIFILM Corporation · Class I
- CANON INC. — CANON INC. · Class II
- DX-M — Agfa Corp. · Class II
- Vita XE CR System — CARESTREAM HEALTH, INC. · Class II
- FUJI IMAGING PLATE — FUJIFILM Corporation · Class I
- CR-IR 392 — FUJIFILM Corporation · Class II
- CANON INC. — CANON INC. · Class II
- GMR40 Retrofit Kit — Neurologica Corporation · Class II
Cleared under the same submission
K052938 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radlink, Inc.
Sources (1)
- FDA UDI 559d4a89-8907-449b-a1e6-32dd0b91463c 34 fields · synced Jun 6, 2026