Identity
- Trade Name
- AWS-c FDA UDI
- Generic Name
- Stationary mammographic x-ray system, digital FDA UDI
- Device Name
- The CR-IR 363AWS is a CR modality workstation intended to associate FCR images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. And the CR-IR 363AWS is suitable for mammography (especially). FDA UDI
- Model / Reference
- CR-IR363AWS FDA UDI
- Description
- The CR-IR 363AWS is a CR modality workstation intended to associate FCR images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. And the CR-IR 363AWS is suitable for mammography (especially). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410316889 FDA UDI
- 510(k) Number
- K042023 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Stationary mammographic 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stationary mammographic x-ray system, digital
AWS-c by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K042023 also covers:
- CR-IR 392 — FUJIFILM Corporation
- CR-IR 392 — FUJIFILM Corporation
- CR-IR 392 — FUJIFILM Corporation
- Dummy Cassette (For Mobile) — FUJIFILM Corporation
- Dummy Cassette (For Mobile) — FUJIFILM Corporation
- FCR CARBON X — FUJIFILM Corporation
- FCR ClearView CS Plus — FUJIFILM Corporation
- FCR ClearView CS Plus — FUJIFILM Corporation
- FCR PRIMA II — FUJIFILM Corporation
- FCR PRIMA T2 — FUJIFILM Corporation
- FCR PRIMA T2 — FUJIFILM Corporation
- FCR PRIMA T2 — 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 2eadcb1d-3a6c-477d-b24a-15b6159d6fc8 35 fields · synced Jun 1, 2026