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FDA 510(k)

POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM

K-Number: K911275 · 1991-05-09

ApplicantPositron
Decision Date1991-05-09
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Positron. It received FDA 510(k) clearance on 1991-05-09 under 510(k) number K911275. 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 POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM?

POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM is a medical device that received FDA 510(k) clearance on 1991-05-09. The listed applicant is Positron. The 510(k) number is K911275.

When did POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM receive FDA 510(k) clearance?

POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM received FDA 510(k) clearance on 1991-05-09, under 510(k) number K911275.

Who is the listed applicant for POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM?

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

What is the FDA product code for POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM?

The FDA product code for POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM 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 Positron 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.

K926206POSICAM-HZ & POSICAM-HZLK894998MODIFIED POSICAM SYSTEM MODEL 6.5K810537AUTOMATIC SCREENING AUDIOMETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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