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)

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ

K-Number: K033431 · 2003-11-20

ApplicantCti Pet Systems, Inc.
Decision Date2003-11-20
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ is the device name listed in this FDA 510(k) record. The listed applicant is Cti Pet Systems, Inc.. It received FDA 510(k) clearance on 2003-11-20 under 510(k) number K033431. 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 LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ?

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ is a medical device that received FDA 510(k) clearance on 2003-11-20. The listed applicant is Cti Pet Systems, Inc.. The 510(k) number is K033431.

When did LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ receive FDA 510(k) clearance?

LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ received FDA 510(k) clearance on 2003-11-20, under 510(k) number K033431.

Who is the listed applicant for LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ?

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

What is the FDA product code for LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ?

The FDA product code for LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ 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

Other records listing Cti Pet Systems, 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.

K050509LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64IK042467LSO PET/CT HIREZ 64K040933ECAT HRRTK023768ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16K023518ECAT LSO PET/CT 16K021633ECAT VISION PET SCANNER, MODELS 3000 & 5000

View all 19 devices →

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.

↑