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FDA 510(k)

CT-MASS

K-Number: K033774 · 2004-03-02

ApplicantMedis Medical Imaging Systems BV
Decision Date2004-03-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT-MASS is the device name listed in this FDA 510(k) record. The listed applicant is Medis Medical Imaging Systems BV. It received FDA 510(k) clearance on 2004-03-02 under 510(k) number K033774. 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-MASS?

CT-MASS is a medical device that received FDA 510(k) clearance on 2004-03-02. The listed applicant is Medis Medical Imaging Systems BV. The 510(k) number is K033774.

When did CT-MASS receive FDA 510(k) clearance?

CT-MASS received FDA 510(k) clearance on 2004-03-02, under 510(k) number K033774.

Who is the listed applicant for CT-MASS?

The FDA 510(k) record lists Medis Medical Imaging Systems BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT-MASS?

The FDA product code for CT-MASS is JAK.

Other records listing Medis Medical Imaging Systems BV 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.

K182611Qangio XA 3DK112807X-RAY VVAK073156QPLAQUE MRK062386QANGIO CTK050703QBRAINK042383RSA-CMS

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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

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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