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FDA 510(k)

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0

K-Number: K203717 · 2021-06-30

ApplicantFujifilm Corporaton
Decision Date2021-06-30
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 is a medical device manufactured by Fujifilm Corporaton. It received FDA 510(k) clearance on 2021-06-30 under approval number K203717. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0?

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 is a medical device that received FDA 510(k) clearance on 2021-06-30. It is manufactured by Fujifilm Corporaton. The 510(k) number is K203717.

When was Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 approved by the FDA?

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 received FDA 510(k) clearance on 2021-06-30, under approval number K203717.

What company makes Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0?

Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 is manufactured by Fujifilm Corporaton.

What is the FDA product code for Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0?

The FDA product code for Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 is GCJ.

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Related PubMed Literature

PMID: 39941212 Artificial Intelligence-Empowered Radiology-Current Status and Critical Review. Diagnostics (Basel, Switzerland) (2025)

Other Devices by Fujifilm Corporaton

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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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