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FDA 510(k)

MEDIPACS

K-Number: K040486 · 2004-03-11

ApplicantNeobit Co., Ltd.
Decision Date2004-03-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MEDIPACS is the device name listed in this FDA 510(k) record. The listed applicant is Neobit Co., Ltd.. It received FDA 510(k) clearance on 2004-03-11 under 510(k) number K040486. 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 MEDIPACS?

MEDIPACS is a medical device that received FDA 510(k) clearance on 2004-03-11. The listed applicant is Neobit Co., Ltd.. The 510(k) number is K040486.

When did MEDIPACS receive FDA 510(k) clearance?

MEDIPACS received FDA 510(k) clearance on 2004-03-11, under 510(k) number K040486.

Who is the listed applicant for MEDIPACS?

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

What is the FDA product code for MEDIPACS?

The FDA product code for MEDIPACS is LLZ.

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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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