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FDA 510(k)

VISION (NUCLEAR MEDICINE COMPUTER)

K-Number: K912573 · 1991-10-28

ApplicantSummit Nuclear
Decision Date1991-10-28
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISION (NUCLEAR MEDICINE COMPUTER) is the device name listed in this FDA 510(k) record. The listed applicant is Summit Nuclear. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K912573. 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 VISION (NUCLEAR MEDICINE COMPUTER)?

VISION (NUCLEAR MEDICINE COMPUTER) is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Summit Nuclear. The 510(k) number is K912573.

When did VISION (NUCLEAR MEDICINE COMPUTER) receive FDA 510(k) clearance?

VISION (NUCLEAR MEDICINE COMPUTER) received FDA 510(k) clearance on 1991-10-28, under 510(k) number K912573.

Who is the listed applicant for VISION (NUCLEAR MEDICINE COMPUTER)?

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

What is the FDA product code for VISION (NUCLEAR MEDICINE COMPUTER)?

The FDA product code for VISION (NUCLEAR MEDICINE COMPUTER) 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 Summit Nuclear 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.

K935273VISION FX 40 & 80 SERIES GAMMA CAMERAK935318SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMSK922427SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEMK922426SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEMK920958SUMMIT NUCLEAR VISION NEUROSPECT

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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