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FDA 510(k)

XELIS 3D

K-Number: K103130 · 2011-07-28

ApplicantInfinitt Co., Ltd.
Decision Date2011-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XELIS 3D is the device name listed in this FDA 510(k) record. The listed applicant is Infinitt Co., Ltd.. It received FDA 510(k) clearance on 2011-07-28 under 510(k) number K103130. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XELIS 3D?

XELIS 3D is a medical device that received FDA 510(k) clearance on 2011-07-28. The listed applicant is Infinitt Co., Ltd.. The 510(k) number is K103130.

When did XELIS 3D receive FDA 510(k) clearance?

XELIS 3D received FDA 510(k) clearance on 2011-07-28, under 510(k) number K103130.

Who is the listed applicant for XELIS 3D?

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

What is the FDA product code for XELIS 3D?

The FDA product code for XELIS 3D is LLZ.

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Other records listing Infinitt Co., Ltd. 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.

K163290INFINITT ULiteK111660XELIS CARDIACK111613XELIS FUSIONK102684XELIS DENTALK082990INFINITT XELISK082706INFINITT CARDIOLOGY PACS

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Related Devices (Code: LLZ)

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

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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