510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861019Substantially Equivalent

Ceiling Mount Counterpoised Secon Radiation Shield

Phase One Disign Co., San Rafael CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861019 is the FDA 510(k) clearance record for CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD, a class I device, cleared for Phase One Disign Co. on under FDA product code EAK (Screen, Leaded, Operator Radiation Protector). FDA records list one 510(k) clearance for Phase One Disign Co. As of , FDA records show no recalls naming K861019.

Clearance record

Decision date
Received
(15 days to decision)
Product code
EAK Screen, Leaded, Operator Radiation Protector
Regulation
21 CFR 892.6500
Device class
Class I
Review panel
Radiology
Applicant
Phase One Disign Co. 1455-I E. Francisco Blvd., San Rafael CA
Third party review
No

Clearances, product code EAK

Trailing 12 months

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

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