Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MINI GAMMA CAMERA, MODEL MGC-500

K-Number: K040587 · 2004-05-14

ApplicantAcrorad Co., Ltd.
Decision Date2004-05-14
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MINI GAMMA CAMERA, MODEL MGC-500 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 2004-05-14 under 510(k) number K040587. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI GAMMA CAMERA, MODEL MGC-500?

MINI GAMMA CAMERA, MODEL MGC-500 is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is Acrorad Co., Ltd.. The 510(k) number is K040587.

When did MINI GAMMA CAMERA, MODEL MGC-500 receive FDA 510(k) clearance?

MINI GAMMA CAMERA, MODEL MGC-500 received FDA 510(k) clearance on 2004-05-14, under 510(k) number K040587.

Who is the listed applicant for MINI GAMMA CAMERA, MODEL MGC-500?

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, MODEL MGC-500?

The FDA product code for MINI GAMMA CAMERA, MODEL MGC-500 is IYX.

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.

K043293MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U

Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K123408ERGO IMAGING SYSTEMDigirad Corp.

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.

↑