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FDA 510(k)

MX8000 IDT CT SYSTEM

K-Number: K012009 · 2001-09-13

ApplicantMarconi Medical Systems, Inc.
Decision Date2001-09-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MX8000 IDT CT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marconi Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-09-13 under 510(k) number K012009. 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 MX8000 IDT CT SYSTEM?

MX8000 IDT CT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-13. The listed applicant is Marconi Medical Systems, Inc.. The 510(k) number is K012009.

When did MX8000 IDT CT SYSTEM receive FDA 510(k) clearance?

MX8000 IDT CT SYSTEM received FDA 510(k) clearance on 2001-09-13, under 510(k) number K012009.

Who is the listed applicant for MX8000 IDT CT SYSTEM?

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

What is the FDA product code for MX8000 IDT CT SYSTEM?

The FDA product code for MX8000 IDT CT SYSTEM 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 Marconi Medical Systems, Inc. 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.

K002005BOLUSPRO ULTRA

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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