510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253192Substantially Equivalent

DeepXray Spina

Alpha Intelligence Manifolds, Inc., New Taipei City, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253192 is the FDA 510(k) clearance record for DeepXray Spina, a class II device, cleared for Alpha Intelligence Manifolds, Inc. on under FDA product code SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density). FDA's definition for product code SAO 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...". FDA records list 2 510(k) clearances for Alpha Intelligence Manifolds, Inc., from to . As of , FDA records show no recalls naming K253192.

Clearance record

Decision date
Received
(257 days to decision)
Product code
SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Regulation
21 CFR 892.1171
Device class
Class II
Review panel
Radiology
Applicant
Alpha Intelligence Manifolds, Inc. 2f, # 170, Zhonghe Rd., Zhonghe Dist., New Taipei City, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAO

Trailing 12 months
1 clearance under product code SAO in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260