Last synced on 14 June 2024 at 11:05 pm

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Page Type
Product Code
Definition
This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.
Physical State
Software device that receives radiological image data as an input and identifies patients with possibly low BMD. It cannot be used to rule out low BMD.
Technical Method
Analyzes radiological data using locked image processing algorithm to estimate BMD values. Software may implement artificial intelligence algorithms. The algorithm training data typically impacts device performance.
Target Area
Human-derived radiological imaging products.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1171
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 SAO is linked to regulation 21CFR892.1171, which does not seem to exist yet. It may be pending at the moment.

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Page Type
Product Code
Definition
This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.
Physical State
Software device that receives radiological image data as an input and identifies patients with possibly low BMD. It cannot be used to rule out low BMD.
Technical Method
Analyzes radiological data using locked image processing algorithm to estimate BMD values. Software may implement artificial intelligence algorithms. The algorithm training data typically impacts device performance.
Target Area
Human-derived radiological imaging products.
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1171
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 SAO is linked to regulation 21CFR892.1171, which does not seem to exist yet. It may be pending at the moment.