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FDA 510(k)

PROTURA COUCH SOFTWARE

K-Number: K132084 · 2013-09-26

ApplicantMed-Tec, Inc. D/B/A Civco Medical Solutions
Decision Date2013-09-26
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PROTURA COUCH SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tec, Inc. D/B/A Civco Medical Solutions. It received FDA 510(k) clearance on 2013-09-26 under 510(k) number K132084. 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 PROTURA COUCH SOFTWARE?

PROTURA COUCH SOFTWARE is a medical device that received FDA 510(k) clearance on 2013-09-26. The listed applicant is Med-Tec, Inc. D/B/A Civco Medical Solutions. The 510(k) number is K132084.

When did PROTURA COUCH SOFTWARE receive FDA 510(k) clearance?

PROTURA COUCH SOFTWARE received FDA 510(k) clearance on 2013-09-26, under 510(k) number K132084.

Who is the listed applicant for PROTURA COUCH SOFTWARE?

The FDA 510(k) record lists Med-Tec, Inc. D/B/A Civco Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTURA COUCH SOFTWARE?

The FDA product code for PROTURA COUCH SOFTWARE 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.

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Other records listing Med-Tec, Inc. D/B/A Civco Medical Solutions 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.

K122201PROTURA COUCH SOFTWARE

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 SystemK122413PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.K122201PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical Solutions

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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