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FDA 510(k)

EMORY CARDIAC TOOLBOX 4.0

K-Number: K123646 · 2013-02-22

ApplicantSyntermed, Inc.
Decision Date2013-02-22
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMORY CARDIAC TOOLBOX 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Syntermed, Inc.. It received FDA 510(k) clearance on 2013-02-22 under 510(k) number K123646. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMORY CARDIAC TOOLBOX 4.0?

EMORY CARDIAC TOOLBOX 4.0 is a medical device that received FDA 510(k) clearance on 2013-02-22. The listed applicant is Syntermed, Inc.. The 510(k) number is K123646.

When did EMORY CARDIAC TOOLBOX 4.0 receive FDA 510(k) clearance?

EMORY CARDIAC TOOLBOX 4.0 received FDA 510(k) clearance on 2013-02-22, under 510(k) number K123646.

Who is the listed applicant for EMORY CARDIAC TOOLBOX 4.0?

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

What is the FDA product code for EMORY CARDIAC TOOLBOX 4.0?

The FDA product code for EMORY CARDIAC TOOLBOX 4.0 is KPS.

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Other records listing Syntermed, Inc. 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.

K130902EMORY CARDIAC TOOLBOX 3.2K130451NEUROQ 3.6K072307QUANTITATIVE NEUROQ 3.0K071503SYSTEM, TOMOGRAPHY, COMPUTED EMISSIONK070089SYNTERMED LIVEK042258BP-SPECT V1.O

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Related Devices (Code: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

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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