FDA 510(k)

PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701

K-Number: K101858 · 2010-07-14

ApplicantShanghai Chenguang Medical Technologies Co, Ltd.

Decision Date2010-07-14

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 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 2010-07-14 under 510(k) number K101858. 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 HEAD-SPINE COIL (MODEL:5000012701?

PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 is a medical device that received FDA 510(k) clearance on 2010-07-14. The listed applicant is Shanghai Chenguang Medical Technologies Co, Ltd.. The 510(k) number is K101858.

When did PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 receive FDA 510(k) clearance?

PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 received FDA 510(k) clearance on 2010-07-14, under 510(k) number K101858.

Who is the listed applicant for PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701?

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 HEAD-SPINE COIL (MODEL:5000012701?

The FDA product code for PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701 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 Shanghai Chenguang Medical Technologies Co, Ltd. as applicant

K112002CAROTID COIL K101949PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601 K092962CAROTID COIL 5000004901 K081340PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201 K081322MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL K071847MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL

View all 8 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.