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FDA 510(k)

GE DEFINIUM AMX 700, MODEL AMX 700

K-Number: K052897 · 2005-11-08

ApplicantGeneral Electric Medical Systems
Decision Date2005-11-08
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE DEFINIUM AMX 700, MODEL AMX 700 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems. It received FDA 510(k) clearance on 2005-11-08 under 510(k) number K052897. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE DEFINIUM AMX 700, MODEL AMX 700?

GE DEFINIUM AMX 700, MODEL AMX 700 is a medical device that received FDA 510(k) clearance on 2005-11-08. The listed applicant is General Electric Medical Systems. The 510(k) number is K052897.

When did GE DEFINIUM AMX 700, MODEL AMX 700 receive FDA 510(k) clearance?

GE DEFINIUM AMX 700, MODEL AMX 700 received FDA 510(k) clearance on 2005-11-08, under 510(k) number K052897.

Who is the listed applicant for GE DEFINIUM AMX 700, MODEL AMX 700?

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

What is the FDA product code for GE DEFINIUM AMX 700, MODEL AMX 700?

The FDA product code for GE DEFINIUM AMX 700, MODEL AMX 700 is IZL.

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Other records listing General Electric Medical Systems 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.

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Related Devices (Code: IZL)

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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