510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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SFVClass II

X-Ray, Computed Tomography, Cone-Beam

21 CFR 892.1750 / Radiology
FDA source (opens on fda.gov)

SFV is the FDA product code for X-Ray, Computed Tomography, Cone-Beam, a class II device type, regulated under 21 CFR 892.1750. FDA's definition for this code reads: "Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SFV
Device name
X-Ray, Computed Tomography, Cone-Beam
FDA definition
Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SFV

By decision year
1 clearance under product code SFV with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SFV by decision year
YearClearances
20251

Applicants with the most clearances

Product code SFV
Applicants holding the most 510(k) clearances under product code SFV
ApplicantClearances
Planmed Oy1

Companies listing this code with FDA

Companies whose registered establishments list this code