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FDA 510(k)

IGUIDE SYSTEM

K-Number: K072079 · 2007-08-14

ApplicantMedical Intelligence Medizintechnik-GmbH-An Elekta
Decision Date2007-08-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IGUIDE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Intelligence Medizintechnik-GmbH-An Elekta. It received FDA 510(k) clearance on 2007-08-14 under 510(k) number K072079. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGUIDE SYSTEM?

IGUIDE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-14. The listed applicant is Medical Intelligence Medizintechnik-GmbH-An Elekta. The 510(k) number is K072079.

When did IGUIDE SYSTEM receive FDA 510(k) clearance?

IGUIDE SYSTEM received FDA 510(k) clearance on 2007-08-14, under 510(k) number K072079.

Who is the listed applicant for IGUIDE SYSTEM?

The FDA 510(k) record lists Medical Intelligence Medizintechnik-GmbH-An Elekta as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGUIDE SYSTEM?

The FDA product code for IGUIDE SYSTEM is IYE.

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 Medical Intelligence Medizintechnik-GmbH-An Elekta 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.

K062639MODIFICATION TO HEXAPOD RT COUCH TOPK062611IGUIDE SYSTEM

Related Devices (Code: IYE)

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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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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