Last synced on 14 June 2024 at 11:05 pm

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Page Type
Product Code
Definition
Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
Physical State
Software application and/or firmware, system components and accessories
Technical Method
Processing radiographic data to assist in the subtyping of ILDs.
Target Area
Human-derived CT imaging products
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2085
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QWO is linked to regulation 21CFR892.2085, which does not seem to exist yet. It may be pending at the moment.

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Page Type
Product Code
Definition
Radiology software for referral of findings related to fibrotic lung disease is a prescription image processing device that analyzes computed tomography images to suggest the presence of disease or of an imaging finding suggestive of disease. The output of this device is intended to be used as adjunctive information as part of a referral pathway in the overall diagnostic assessment process.
Physical State
Software application and/or firmware, system components and accessories
Technical Method
Processing radiographic data to assist in the subtyping of ILDs.
Target Area
Human-derived CT imaging products
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.2085
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QWO is linked to regulation 21CFR892.2085, which does not seem to exist yet. It may be pending at the moment.