FDA 510(k)

Curve Image 2.0 PACS

K-Number: K173101 · 2017-10-18

Decision Date2017-10-18

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Curve Image 2.0 PACS is the device name listed in this FDA 510(k) record. The listed applicant is Curve Dental, Ltd.. It received FDA 510(k) clearance on 2017-10-18 under 510(k) number K173101. 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 Curve Image 2.0 PACS?

Curve Image 2.0 PACS is a medical device that received FDA 510(k) clearance on 2017-10-18. The listed applicant is Curve Dental, Ltd.. The 510(k) number is K173101.

When did Curve Image 2.0 PACS receive FDA 510(k) clearance?

Curve Image 2.0 PACS received FDA 510(k) clearance on 2017-10-18, under 510(k) number K173101.

Who is the listed applicant for Curve Image 2.0 PACS?

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

What is the FDA product code for Curve Image 2.0 PACS?

The FDA product code for Curve Image 2.0 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.