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FDA 510(k)

MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U

K-Number: K043293 · 2004-12-17

ApplicantAcrorad Co., Ltd.
Decision Date2004-12-17
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U is the device name listed in this FDA 510(k) record. The listed applicant is Acrorad Co., Ltd.. It received FDA 510(k) clearance on 2004-12-17 under 510(k) number K043293. 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 MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U?

MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U is a medical device that received FDA 510(k) clearance on 2004-12-17. The listed applicant is Acrorad Co., Ltd.. The 510(k) number is K043293.

When did MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U receive FDA 510(k) clearance?

MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U received FDA 510(k) clearance on 2004-12-17, under 510(k) number K043293.

Who is the listed applicant for MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U?

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

What is the FDA product code for MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U?

The FDA product code for MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U 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 Acrorad Co., Ltd. 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.

K040587MINI GAMMA CAMERA, MODEL MGC-500

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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