510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SAOClass II

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

21 CFR 892.1171 / Radiology
FDA source (opens on fda.gov)

SAO is the FDA product code for Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density, a class II device type, regulated under 21 CFR 892.1171. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SAO
Device name
Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
FDA 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.
Regulation
21 CFR 892.1171
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code SAO

By decision year
3 clearances under product code SAO with a decision year between 2024 and 2026, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SAO by decision year
YearClearances
20241
20251
20261

Applicants with the most clearances

Product code SAO
Applicants holding the most 510(k) clearances under product code SAO
ApplicantClearances
16 Bit Inc1
Alpha Intelligence Manifolds, Inc.1
Naitive Technologies Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code