510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050190Substantially Equivalent

Apollo

Villa Sistemi Medicali S.p.A., Franklin Park IL / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050190 is the FDA 510(k) clearance record for APOLLO, a class II device, cleared for Villa Sistemi Medicali S.P.A. on under FDA product code KXJ (Table, Radiologic). FDA records list 13 510(k) clearances for Villa Sistemi Medicali S.P.A., from to . As of , FDA records show 15 recalls naming K050190.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KXJ Table, Radiologic
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Villa Sistemi Medicali S.P.A. 11550 W. King St., Franklin Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXJ

Trailing 12 months

FDA records hold no clearances under product code KXJ in the trailing twelve months.

FDA records show no clearances under product code KXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260