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FDA 510(k)

BA-004CC

K-Number: K261170 · 2026-08-12

ApplicantFujifilm Corporation
Decision Date2026-08-12
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BA-004CC is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2026-08-12 under 510(k) number K261170. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BA-004CC?

BA-004CC is a medical device that received FDA 510(k) clearance on 2026-08-12. The listed applicant is Fujifilm Corporation. The 510(k) number is K261170.

When did BA-004CC receive FDA 510(k) clearance?

BA-004CC received FDA 510(k) clearance on 2026-08-12, under 510(k) number K261170.

Who is the listed applicant for BA-004CC?

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

What is the FDA product code for BA-004CC?

The FDA product code for BA-004CC is ITX.

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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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