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FDA 510(k)

DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION

K-Number: K013481 · 2001-11-02

ApplicantGE Medical Systems
Decision Date2001-11-02
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2001-11-02 under 510(k) number K013481. 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 DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION?

DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION is a medical device that received FDA 510(k) clearance on 2001-11-02. The listed applicant is GE Medical Systems. The 510(k) number is K013481.

When did DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION receive FDA 510(k) clearance?

DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION received FDA 510(k) clearance on 2001-11-02, under 510(k) number K013481.

Who is the listed applicant for DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION?

The FDA 510(k) record lists GE Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION?

The FDA product code for DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION is KPR.

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Other records listing GE Medical Systems 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.

K253808AIR Recon DLK220848Venue FitK220851VenueK173341Vivid E80, Vivid E90, Vivid E95K103411IDEAL IQ SOFTWARE OPTIONK073138CARDIQ EXPRESS VERSION 2.0

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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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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