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FDA 510(k)

AMX-4 PLUS MOBILE X-RAY SYSTEM

K-Number: K021016 · 2002-06-17

ApplicantGE Medical Systems
Decision Date2002-06-17
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMX-4 PLUS MOBILE X-RAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2002-06-17 under 510(k) number K021016. 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 AMX-4 PLUS MOBILE X-RAY SYSTEM?

AMX-4 PLUS MOBILE X-RAY SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-17. The listed applicant is GE Medical Systems. The 510(k) number is K021016.

When did AMX-4 PLUS MOBILE X-RAY SYSTEM receive FDA 510(k) clearance?

AMX-4 PLUS MOBILE X-RAY SYSTEM received FDA 510(k) clearance on 2002-06-17, under 510(k) number K021016.

Who is the listed applicant for AMX-4 PLUS MOBILE X-RAY SYSTEM?

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

What is the FDA product code for AMX-4 PLUS MOBILE X-RAY SYSTEM?

The FDA product code for AMX-4 PLUS MOBILE X-RAY SYSTEM is IZL.

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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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