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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporaton. It received FDA 510(k) clearance on 2021-06-30 under 510(k) 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. The listed applicant is Fujifilm Corporaton. The 510(k) number is K203717.

When did Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0?

The FDA 510(k) record lists Fujifilm Corporaton as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Fujifilm Corporaton as applicant

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.

K221551FUJIFILM Endoscope Model EI-740D/SK223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DK220957FUJIFILM Endoscope Model EB-710PK212950FUJIFILM Video Laparoscope EL-R740M30K200973Synapse 3D Cardiac Tools

Related Devices (Code: GCJ)

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

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