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FDA 510(k)

ONIS-PACS

K-Number: K181318 · 2018-08-13

ApplicantDigitalcore Co., Ltd.
Decision Date2018-08-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONIS-PACS is a medical device manufactured by Digitalcore Co., Ltd.. It received FDA 510(k) clearance on 2018-08-13 under approval 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. It is manufactured by Digitalcore Co., Ltd.. The 510(k) number is K181318.

When was ONIS-PACS approved by the FDA?

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

What company makes ONIS-PACS?

ONIS-PACS is manufactured by Digitalcore Co., Ltd..

What is the FDA product code for ONIS-PACS?

The FDA product code for ONIS-PACS is LLZ.

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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.

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