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FDA 510(k)

CARDIUS 3 X-ACT

K-Number: K083649 · 2009-03-09

ApplicantDigirad Corp.
Decision Date2009-03-09
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIUS 3 X-ACT is the device name listed in this FDA 510(k) record. The listed applicant is Digirad Corp.. It received FDA 510(k) clearance on 2009-03-09 under 510(k) number K083649. 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 CARDIUS 3 X-ACT?

CARDIUS 3 X-ACT is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Digirad Corp.. The 510(k) number is K083649.

When did CARDIUS 3 X-ACT receive FDA 510(k) clearance?

CARDIUS 3 X-ACT received FDA 510(k) clearance on 2009-03-09, under 510(k) number K083649.

Who is the listed applicant for CARDIUS 3 X-ACT?

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

What is the FDA product code for CARDIUS 3 X-ACT?

The FDA product code for CARDIUS 3 X-ACT is KPS.

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Other records listing Digirad Corp. 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.

K123408ERGO IMAGING SYSTEMK100838ERGO IMAGING SYSTEMK082904STASYS MOTION CORRECTION SOFTWAREK082368CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEMK070542CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMSK052430CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM

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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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