Synapse 3D Nodule Analysis

by Fujifilm Medical Systems U.S.A, Inc. 510(k)

Active United States

510(k) K120679

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK120679	Date1 Jun 2012Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K120679
FDA Product Code: LLZ

Device Class: Class II
Regulation: 21 CFR Part 892.2050
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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