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FDA 510(k)

ALIGNRT

K-Number: K052682 · 2006-01-06

Decision Date2006-01-06
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALIGNRT is the device name listed in this FDA 510(k) record. The listed applicant is Vision RT Limited. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K052682. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIGNRT?

ALIGNRT is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Vision RT Limited. The 510(k) number is K052682.

When did ALIGNRT receive FDA 510(k) clearance?

ALIGNRT received FDA 510(k) clearance on 2006-01-06, under 510(k) number K052682.

Who is the listed applicant for ALIGNRT?

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

What is the FDA product code for ALIGNRT?

The FDA product code for ALIGNRT is IYE.

Related Clinical Trials

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.

Other records listing Vision RT Limited 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.

Related Devices (Code: IYE)

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.

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.

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