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FDA 510(k)

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

K-Number: K253628 · 2026-06-29

ApplicantAgada Medical, Ltd.
Decision Date2026-06-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) is the device name listed in this FDA 510(k) record. The listed applicant is Agada Medical, Ltd.. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253628. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Agada Medical, Ltd.. The 510(k) number is K253628.

When did Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) receive FDA 510(k) clearance?

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253628.

Who is the listed applicant for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?

The FDA 510(k) record lists Agada Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?

The FDA product code for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) is QIH.

Related Devices (Code: QIH)

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Official Source

View on FDA Database →

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

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