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FDA 510(k)

3DSCOPE

K-Number: K041213 · 2004-07-22

ApplicantDirex Systems Corp.
Decision Date2004-07-22
Product CodeOXO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3DSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Direx Systems Corp.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041213. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3DSCOPE?

3DSCOPE is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is Direx Systems Corp.. The 510(k) number is K041213.

When did 3DSCOPE receive FDA 510(k) clearance?

3DSCOPE received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041213.

Who is the listed applicant for 3DSCOPE?

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

What is the FDA product code for 3DSCOPE?

The FDA product code for 3DSCOPE is OXO.

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Other records listing Direx Systems Corp. 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.

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Related Devices (Code: OXO)

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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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