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FDA 510(k)

IMAGEN3D

K-Number: K122241 · 2012-10-24

ApplicantCardiovascular Imaging Technologies
Decision Date2012-10-24
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMAGEN3D is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Technologies. It received FDA 510(k) clearance on 2012-10-24 under 510(k) number K122241. 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 IMAGEN3D?

IMAGEN3D is a medical device that received FDA 510(k) clearance on 2012-10-24. The listed applicant is Cardiovascular Imaging Technologies. The 510(k) number is K122241.

When did IMAGEN3D receive FDA 510(k) clearance?

IMAGEN3D received FDA 510(k) clearance on 2012-10-24, under 510(k) number K122241.

Who is the listed applicant for IMAGEN3D?

The FDA 510(k) record lists Cardiovascular Imaging Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGEN3D?

The FDA product code for IMAGEN3D is KPS.

Related Clinical Trials

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Other records listing Cardiovascular Imaging Technologies 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.

K201933ImagenSPECT 3.0K173547ImagenUniversalK152503ImagenSPECT

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

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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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