FDA 510(k)

ScanDiags Ortho L-Spine MR-Q

K-Number: K242607 · 2025-02-21

Decision Date2025-02-21

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ScanDiags Ortho L-Spine MR-Q is the device name listed in this FDA 510(k) record. The listed applicant is Scandiags AG. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K242607. 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 ScanDiags Ortho L-Spine MR-Q?

ScanDiags Ortho L-Spine MR-Q is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Scandiags AG. The 510(k) number is K242607.

When did ScanDiags Ortho L-Spine MR-Q receive FDA 510(k) clearance?

ScanDiags Ortho L-Spine MR-Q received FDA 510(k) clearance on 2025-02-21, under 510(k) number K242607.

Who is the listed applicant for ScanDiags Ortho L-Spine MR-Q?

The FDA 510(k) record lists Scandiags AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ScanDiags Ortho L-Spine MR-Q?

The FDA product code for ScanDiags Ortho L-Spine MR-Q is QIH.

Related Devices (Code: QIH)

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.

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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.