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FDA 510(k)

ECAT EXACT & ECAT EXACT HR+

K-Number: K962797 · 1996-10-15

ApplicantCti Pet Systems, Inc.
Decision Date1996-10-15
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECAT EXACT & ECAT EXACT HR+ 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 1996-10-15 under 510(k) number K962797. 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 ECAT EXACT & ECAT EXACT HR+?

ECAT EXACT & ECAT EXACT HR+ is a medical device that received FDA 510(k) clearance on 1996-10-15. The listed applicant is Cti Pet Systems, Inc.. The 510(k) number is K962797.

When did ECAT EXACT & ECAT EXACT HR+ receive FDA 510(k) clearance?

ECAT EXACT & ECAT EXACT HR+ received FDA 510(k) clearance on 1996-10-15, under 510(k) number K962797.

Who is the listed applicant for ECAT EXACT & ECAT EXACT HR+?

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 ECAT EXACT & ECAT EXACT HR+?

The FDA product code for ECAT EXACT & ECAT EXACT HR+ 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 HRRTK033431LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZK023768ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16K023518ECAT LSO PET/CT 16

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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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