Identity
- Trade Name
- InferRead Lung CT.AI FDA UDI
- Generic Name
- X-ray image interpretive software FDA UDI
- Device Name
- InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest. FDA UDI
- Model / Reference
- 5.0.2.5 FDA UDI
- Description
- InferRead Lung CT.AI is comprised of computer assisted reading tools designed to aid the radiologist in the detection of pulmonary nodules during the review of CT examinations of the chest. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850003095042 FDA UDI
- 510(k) Number
- K240554 FDA UDI
- FDA Product Code
- OEB FDA UDIQIH FDA UDI
- GMDN Term
- X-ray image interpretive software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Diagnostic x-ray digital imaging system workstationX-ray image interpretive software
InferRead Lung CT.AI by Infervision Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Infervision Medical Technology Co., Ltd
Sources (1)
- FDA UDI 462153a3-9f13-49d3-aa20-171cba5efc86 34 fields · synced May 29, 2026