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FDA 510(k)

REMOTE VIEW SOFTWARE

K-Number: K111321 · 2011-05-17

ApplicantCariescan , Ltd.
Decision Date2011-05-17
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMOTE VIEW SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Cariescan , Ltd.. It received FDA 510(k) clearance on 2011-05-17 under 510(k) number K111321. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOTE VIEW SOFTWARE?

REMOTE VIEW SOFTWARE is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Cariescan , Ltd.. The 510(k) number is K111321.

When did REMOTE VIEW SOFTWARE receive FDA 510(k) clearance?

REMOTE VIEW SOFTWARE received FDA 510(k) clearance on 2011-05-17, under 510(k) number K111321.

Who is the listed applicant for REMOTE VIEW SOFTWARE?

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

What is the FDA product code for REMOTE VIEW SOFTWARE?

The FDA product code for REMOTE VIEW SOFTWARE is NBL.

Related Clinical Trials

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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Other records listing Cariescan , 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.

K090598CARIESCAN PRO

Related Devices (Code: NBL)

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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