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FDA 510(k)

Synapse 3D Base Tools (V7.0)

K-Number: K243762 · 2025-05-21

ApplicantFujifilm Corporation
Decision Date2025-05-21
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Synapse 3D Base Tools (V7.0) is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K243762. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Synapse 3D Base Tools (V7.0)?

Synapse 3D Base Tools (V7.0) is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Fujifilm Corporation. The 510(k) number is K243762.

When did Synapse 3D Base Tools (V7.0) receive FDA 510(k) clearance?

Synapse 3D Base Tools (V7.0) received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243762.

Who is the listed applicant for Synapse 3D Base Tools (V7.0)?

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 Synapse 3D Base Tools (V7.0)?

The FDA product code for Synapse 3D Base Tools (V7.0) is QIH.

Other records listing Fujifilm Corporation 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.

K261170BA-004CCK260567EW10-EC02 Endoscopy Support ProgramK261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TK254075Synapse Lung Nodule AIK254189Synapse 3D Base Tools (V7.2)

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

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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