FDA 510(k)

MODEL 445SI-64E QUADRATURE WRIST COIL

K-Number: K000589 · 2000-03-14

Decision Date2000-03-14

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODEL 445SI-64E QUADRATURE WRIST COIL is the device name listed in this FDA 510(k) record. The listed applicant is Igc-Medical Advances, Inc.. It received FDA 510(k) clearance on 2000-03-14 under 510(k) number K000589. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 445SI-64E QUADRATURE WRIST COIL?

MODEL 445SI-64E QUADRATURE WRIST COIL is a medical device that received FDA 510(k) clearance on 2000-03-14. The listed applicant is Igc-Medical Advances, Inc.. The 510(k) number is K000589.

When did MODEL 445SI-64E QUADRATURE WRIST COIL receive FDA 510(k) clearance?

MODEL 445SI-64E QUADRATURE WRIST COIL received FDA 510(k) clearance on 2000-03-14, under 510(k) number K000589.

Who is the listed applicant for MODEL 445SI-64E QUADRATURE WRIST COIL?

The FDA 510(k) record lists Igc-Medical Advances, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 445SI-64E QUADRATURE WRIST COIL?

The FDA product code for MODEL 445SI-64E QUADRATURE WRIST COIL is MOS.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Igc-Medical Advances, Inc. as applicant

K041185TORSO ARRAY COIL, MODEL 558GE-64 K040640MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL K033292AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 K023848MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:K003366MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL K001312MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL

View all 7 devices →

Related Devices (Code: MOS)

K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TPhilips Medical Systems Nederland B.V.K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TPhilips Medical Systems Nederland B.V.K2609470.55T 12Ch Breast CoilNeocoil, LLC K252587HD 8Ch Wrist ArrayShenzhen RF Tech Co., Ltd.K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive OnlyShenzhen RF Tech Co., Ltd.K260519Smart Fit TorsoCardiac 1.5TPhilips Healthcare (Suzhou) Co., 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.