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FDA 510(k)

PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0

K-Number: K130165 · 2013-08-30

ApplicantAdvanced Planimetric Services, LLC
Decision Date2013-08-30
Product CodeFXN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Planimetric Services, LLC. It received FDA 510(k) clearance on 2013-08-30 under 510(k) number K130165. The device is classified under product code FXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0?

PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 is a medical device that received FDA 510(k) clearance on 2013-08-30. The listed applicant is Advanced Planimetric Services, LLC. The 510(k) number is K130165.

When did PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 receive FDA 510(k) clearance?

PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 received FDA 510(k) clearance on 2013-08-30, under 510(k) number K130165.

Who is the listed applicant for PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0?

The FDA 510(k) record lists Advanced Planimetric Services, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0?

The FDA product code for PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0 is FXN.

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Related Devices (Code: FXN)

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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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