510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161900Substantially Equivalent

Hyperion X5

Cefla S.C., Imola, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161900 is the FDA 510(k) clearance record for HYPERION X5, a class II device, cleared for Cefla S.C. on under FDA product code OAS (X-Ray, Tomography, Computed, Dental). FDA's definition for product code OAS reads: "Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth". FDA records list 23 510(k) clearances for Cefla S.C., from to . As of , FDA records show no recalls naming K161900.

Clearance record

Decision date
Received
(151 days to decision)
Product code
OAS X-Ray, Tomography, Computed, Dental
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Cefla S.C. Via Selice Provinciale 13/A, Imola, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OAS

Trailing 12 months
10 clearances under product code OAS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OAS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20261
March 20262
April 20261
May 20261
June 20262
July 20261
August 20260
September 20260
October 20260