FDA 510(k)

DeepXray Spina

K-Number: K253192 · 2026-06-10

ApplicantAlpha Intelligence Manifolds, Inc.

Decision Date2026-06-10

Product CodeSAO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DeepXray Spina is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Intelligence Manifolds, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K253192. The device is classified under product code SAO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DeepXray Spina?

DeepXray Spina is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Alpha Intelligence Manifolds, Inc.. The 510(k) number is K253192.

When did DeepXray Spina receive FDA 510(k) clearance?

DeepXray Spina received FDA 510(k) clearance on 2026-06-10, under 510(k) number K253192.

Who is the listed applicant for DeepXray Spina?

The FDA 510(k) record lists Alpha Intelligence Manifolds, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepXray Spina?

The FDA product code for DeepXray Spina is SAO.

Other records listing Alpha Intelligence Manifolds, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223621DeepXray

Related Devices (Code: SAO)

K251408OsteoSight™ Hip (v1)Naitive Technologies, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.