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FDA 510(k)

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4

K-Number: K173507 · 2018-06-15

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2018-06-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2018-06-15 under approval number K173507. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prodiva 1.5T CX and Prodiva 1.5T CS R5.4?

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 is a medical device that received FDA 510(k) clearance on 2018-06-15. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K173507.

When was Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 approved by the FDA?

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 received FDA 510(k) clearance on 2018-06-15, under approval number K173507.

What company makes Prodiva 1.5T CX and Prodiva 1.5T CS R5.4?

Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 is manufactured by Philips Healthcare (Suzhou) Co., Ltd..

What is the FDA product code for Prodiva 1.5T CX and Prodiva 1.5T CS R5.4?

The FDA product code for Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 is LNH.

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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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