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FDA 510(k)

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100

K-Number: K034054 · 2004-02-20

ApplicantMed-Tec,Inc.
Decision Date2004-02-20
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tec,Inc.. It received FDA 510(k) clearance on 2004-02-20 under 510(k) number K034054. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100?

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 is a medical device that received FDA 510(k) clearance on 2004-02-20. The listed applicant is Med-Tec,Inc.. The 510(k) number is K034054.

When did PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 receive FDA 510(k) clearance?

PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 received FDA 510(k) clearance on 2004-02-20, under 510(k) number K034054.

Who is the listed applicant for PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100?

The FDA 510(k) record lists Med-Tec,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100?

The FDA product code for PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 is JAI.

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Other records listing Med-Tec,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.

K031866MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DACK021360SCINTILLATING FIBER DOSIMETER (SFD), MODEL MT-SFD-1000K023293MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02K013875MED-TEC COMPENSATOR BLOCK CUTTER SOFTWAREK001052MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFXK981992ELECTRON WEDGE MODEL MT-EW-1000

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Related Devices (Code: JAI)

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.

K231612Eve Patient Positioner SystemLeo Cancer CareK182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc.K170502Patient Positioning SystemForte Automation Systems, Inc.K160518LEONI ORION SystemLeoni Cia Cable SystemK132084PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical SolutionsK122413PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.

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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