FDA 510(k)

ONIS-PACS

K-Number: K181318 · 2018-08-13

Decision Date2018-08-13

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ONIS-PACS is the device name listed in this FDA 510(k) record. The listed applicant is Digitalcore Co., Ltd.. It received FDA 510(k) clearance on 2018-08-13 under 510(k) number K181318. 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 ONIS-PACS?

ONIS-PACS is a medical device that received FDA 510(k) clearance on 2018-08-13. The listed applicant is Digitalcore Co., Ltd.. The 510(k) number is K181318.

When did ONIS-PACS receive FDA 510(k) clearance?

ONIS-PACS received FDA 510(k) clearance on 2018-08-13, under 510(k) number K181318.

Who is the listed applicant for ONIS-PACS?

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

What is the FDA product code for ONIS-PACS?

The FDA product code for ONIS-PACS is LLZ.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.