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FDA 510(k)

CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS

K-Number: K041542 · 2004-06-17

ApplicantNeusoft Digital Medical Systems Co., Ltd.
Decision Date2004-06-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Neusoft Digital Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2004-06-17 under 510(k) number K041542. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS?

CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-06-17. The listed applicant is Neusoft Digital Medical Systems Co., Ltd.. The 510(k) number is K041542.

When did CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS receive FDA 510(k) clearance?

CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS received FDA 510(k) clearance on 2004-06-17, under 510(k) number K041542.

Who is the listed applicant for CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS?

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

What is the FDA product code for CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS?

The FDA product code for CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS is JAK.

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.

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Other records listing Neusoft Digital Medical Systems 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.

K033315SUPEROPEN 0.23T, MODEL NAM-P023AK030918SUPEROPEN 0.35T, MODEL NSM-P035K020913CT-C3000 SPIRAL CT SCANNER SYSTEM

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

Official Source

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