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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 the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2018-06-15 under 510(k) 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. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K173507.

When did Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 receive FDA 510(k) clearance?

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

Who is the listed applicant for Prodiva 1.5T CX and Prodiva 1.5T CS R5.4?

The FDA 510(k) record lists Philips Healthcare (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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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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