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FDA 510(k)

MOBILE COMPACT DIGITAL CARDIAC CAMERA

K-Number: K040057 · 2004-02-02

ApplicantIs2 Research, Inc.
Decision Date2004-02-02
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOBILE COMPACT DIGITAL CARDIAC CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Is2 Research, Inc.. It received FDA 510(k) clearance on 2004-02-02 under 510(k) number K040057. 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 MOBILE COMPACT DIGITAL CARDIAC CAMERA?

MOBILE COMPACT DIGITAL CARDIAC CAMERA is a medical device that received FDA 510(k) clearance on 2004-02-02. The listed applicant is Is2 Research, Inc.. The 510(k) number is K040057.

When did MOBILE COMPACT DIGITAL CARDIAC CAMERA receive FDA 510(k) clearance?

MOBILE COMPACT DIGITAL CARDIAC CAMERA received FDA 510(k) clearance on 2004-02-02, under 510(k) number K040057.

Who is the listed applicant for MOBILE COMPACT DIGITAL CARDIAC CAMERA?

The FDA 510(k) record lists Is2 Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBILE COMPACT DIGITAL CARDIAC CAMERA?

The FDA product code for MOBILE COMPACT DIGITAL CARDIAC CAMERA is KPS.

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Other records listing Is2 Research, 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.

K033956MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)K032779MODIFICATION TO: NUCAMMA RXK013667BCC GAMMA CAMERAK003882NUCAMMA BI90K982045NUCAMMA RXK982044NUCAMMA R+

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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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