FDA 510(k) clearance · back to tracker

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

Fluoptics Sas (A Getinge Group Company) cleared K233564 on 2023-12-15, decision: substantially equivalent

K-number

K233564

Sponsor

Fluoptics Sas (A Getinge Group Company)

Device

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-12-15

Product code

QDG

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4550

Official FDA record

Open K233564on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.