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FDA 510(k)

4D View

K-Number: K182750 · 2018-12-21

ApplicantGE Medical Systems Ultrasound and Primary Care Diagnostics
Decision Date2018-12-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4D View is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K182750. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4D View?

4D View is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K182750.

When did 4D View receive FDA 510(k) clearance?

4D View received FDA 510(k) clearance on 2018-12-21, under 510(k) number K182750.

Who is the listed applicant for 4D View?

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

What is the FDA product code for 4D View?

The FDA product code for 4D View is LLZ.

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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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