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FDA 510(k)

ECAT SCANNER (MODEL 921)

K-Number: K913637 · 1991-11-27

ApplicantCti Pet Systems, Inc.
Decision Date1991-11-27
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECAT SCANNER (MODEL 921) 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 1991-11-27 under 510(k) number K913637. 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 SCANNER (MODEL 921)?

ECAT SCANNER (MODEL 921) is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Cti Pet Systems, Inc.. The 510(k) number is K913637.

When did ECAT SCANNER (MODEL 921) receive FDA 510(k) clearance?

ECAT SCANNER (MODEL 921) received FDA 510(k) clearance on 1991-11-27, under 510(k) number K913637.

Who is the listed applicant for ECAT SCANNER (MODEL 921)?

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 SCANNER (MODEL 921)?

The FDA product code for ECAT SCANNER (MODEL 921) 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

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.

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