510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935273Substantially Equivalent

Vision Fx 40 & 80 Series Gamma Camera

Summit Nuclear, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935273 is the FDA 510(k) clearance record for VISION FX 40 & 80 SERIES GAMMA CAMERA, a class I device, cleared for Summit Nuclear on under FDA product code IYX (Camera, Scintillation (Gamma)). FDA records list 6 510(k) clearances for Summit Nuclear, from to . As of , FDA records show 2 recalls naming K935273.

Clearance record

Decision date
Received
(167 days to decision)
Product code
IYX Camera, Scintillation (Gamma)
Regulation
21 CFR 892.1100
Device class
Class I
Review panel
Radiology
Applicant
Summit Nuclear 1993 Case Pkwy., Twinsburg OH
510(k) summary
Summary
Third party review
No

Clearances, product code IYX

Trailing 12 months

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

FDA records show no clearances under product code IYX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IYX, 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