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FDA 510(k)

PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601

K-Number: K101949 · 2010-07-28

ApplicantShanghai Chenguang Medical Technologies Co, Ltd.
Decision Date2010-07-28
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Chenguang Medical Technologies Co, Ltd.. It received FDA 510(k) clearance on 2010-07-28 under 510(k) number K101949. 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 PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601?

PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 is a medical device that received FDA 510(k) clearance on 2010-07-28. The listed applicant is Shanghai Chenguang Medical Technologies Co, Ltd.. The 510(k) number is K101949.

When did PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 receive FDA 510(k) clearance?

PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 received FDA 510(k) clearance on 2010-07-28, under 510(k) number K101949.

Who is the listed applicant for PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601?

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

What is the FDA product code for PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601?

The FDA product code for PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 is MOS.

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Other records listing Shanghai Chenguang Medical Technologies 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.

K112002CAROTID COILK101858PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701K092962CAROTID COIL 5000004901K081340PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201K081322MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COILK071847MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL

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Related Devices (Code: MOS)

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.

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, LLCK252587HD 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.

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