510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K811677Substantially Equivalent

Krypton Cart

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

K811677 is the FDA 510(k) clearance record for KRYPTON CART, a class I device, cleared for Medi-Physics Inc. Dba Nycomed Amersham Imaging on under FDA product code KPY (Shield, Protective, Personnel). 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 K811677.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KPY Shield, Protective, Personnel
Regulation
21 CFR 892.6500
Device class
Class I
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 KPY

Trailing 12 months

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

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