Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COMPACT DIGITAL CARDIAC CAMERA (CDCC)

K-Number: K033199 · 2003-11-12

ApplicantIs2 Medical Systems, Inc.
Decision Date2003-11-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COMPACT DIGITAL CARDIAC CAMERA (CDCC) is the device name listed in this FDA 510(k) record. The listed applicant is Is2 Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K033199. 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 COMPACT DIGITAL CARDIAC CAMERA (CDCC)?

COMPACT DIGITAL CARDIAC CAMERA (CDCC) is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Is2 Medical Systems, Inc.. The 510(k) number is K033199.

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

COMPACT DIGITAL CARDIAC CAMERA (CDCC) received FDA 510(k) clearance on 2003-11-12, under 510(k) number K033199.

Who is the listed applicant for COMPACT DIGITAL CARDIAC CAMERA (CDCC)?

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

What is the FDA product code for COMPACT DIGITAL CARDIAC CAMERA (CDCC)?

The FDA product code for COMPACT DIGITAL CARDIAC CAMERA (CDCC) is KPS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑