510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811118Substantially Equivalent

Krypton Masks & Tubing

Medi-Physics Inc. dba Nycomed Amersham Imaging, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811118 is the FDA 510(k) clearance record for KRYPTON MASKS & TUBING, a class II device, cleared for Medi-Physics Inc. Dba Nycomed Amersham Imaging on under FDA product code IYT (System, Rebreathing, Radionuclide). FDA records list 9 510(k) clearances for Medi-Physics Inc. Dba Nycomed Amersham Imaging, from to . As of , FDA records show no recalls naming K811118.

Clearance record

Decision date
Received
(39 days to decision)
Product code
IYT System, Rebreathing, Radionuclide
Regulation
21 CFR 892.1390
Device class
Class II
Review panel
Radiology
Applicant
Medi-Physics Inc. Dba Nycomed Amersham Imaging 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IYT

Trailing 12 months
1 clearance under product code IYT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code IYT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260