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FDA 510(k)

FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION

K-Number: K122454 · 2012-11-20

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2012-11-20
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2012-11-20 under 510(k) number K122454. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION?

FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION is a medical device that received FDA 510(k) clearance on 2012-11-20. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K122454.

When did FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION receive FDA 510(k) clearance?

FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION received FDA 510(k) clearance on 2012-11-20, under 510(k) number K122454.

Who is the listed applicant for FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION?

The FDA product code for FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION is KPR.

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Other records listing Fujifilm Medical System U.S.A., Inc. as applicant

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Related Devices (Code: KPR)

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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