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FDA 510(k)

4D View

K-Number: K182750 · 2018-12-21

Decision Date2018-12-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

4D View is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2018-12-21 under approval 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. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K182750.

When was 4D View approved by the FDA?

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

What company makes 4D View?

4D View is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for 4D View?

The FDA product code for 4D View is LLZ.

Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics

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Related Devices (Code: LLZ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.