Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC

K-Number: K031866 · 2003-08-14

ApplicantMed-Tec,Inc.
Decision Date2003-08-14
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC 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 2003-08-14 under 510(k) number K031866. 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 MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC?

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC is a medical device that received FDA 510(k) clearance on 2003-08-14. The listed applicant is Med-Tec,Inc.. The 510(k) number is K031866.

When did MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC receive FDA 510(k) clearance?

MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC received FDA 510(k) clearance on 2003-08-14, under 510(k) number K031866.

Who is the listed applicant for MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC?

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 MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC?

The FDA product code for MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DAC is JAI.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K034054PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100K021360SCINTILLATING 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

View all 8 devices →

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.

↑