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FDA 510(k)

Spine Auto Views

K-Number: K223424 · 2023-07-13

ApplicantGE Medical Systems SCS
Decision Date2023-07-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Spine Auto Views is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2023-07-13 under 510(k) number K223424. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spine Auto Views?

Spine Auto Views is a medical device that received FDA 510(k) clearance on 2023-07-13. The listed applicant is GE Medical Systems SCS. The 510(k) number is K223424.

When did Spine Auto Views receive FDA 510(k) clearance?

Spine Auto Views received FDA 510(k) clearance on 2023-07-13, under 510(k) number K223424.

Who is the listed applicant for Spine Auto Views?

The FDA 510(k) record lists GE Medical Systems SCS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spine Auto Views?

The FDA product code for Spine Auto Views is JAK.

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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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