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FDA 510(k)

MAPCHECK2, ARCCHECK

K-Number: K131466 · 2013-08-20

ApplicantSun Nuclear Corporation
Decision Date2013-08-20
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAPCHECK2, ARCCHECK is the device name listed in this FDA 510(k) record. The listed applicant is Sun Nuclear Corporation. It received FDA 510(k) clearance on 2013-08-20 under 510(k) number K131466. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAPCHECK2, ARCCHECK?

MAPCHECK2, ARCCHECK is a medical device that received FDA 510(k) clearance on 2013-08-20. The listed applicant is Sun Nuclear Corporation. The 510(k) number is K131466.

When did MAPCHECK2, ARCCHECK receive FDA 510(k) clearance?

MAPCHECK2, ARCCHECK received FDA 510(k) clearance on 2013-08-20, under 510(k) number K131466.

Who is the listed applicant for MAPCHECK2, ARCCHECK?

The FDA 510(k) record lists Sun Nuclear Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAPCHECK2, ARCCHECK?

The FDA product code for MAPCHECK2, ARCCHECK is IYE.

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Other records listing Sun Nuclear Corporation 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.

K170307SunCHECKK161946DoseCHECKK160057ArcCHECK-MRK1318623DVHK131704EPIDOSE

Related Devices (Code: IYE)

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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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