510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844180Substantially Equivalent

The Mcp-70-Se System

Ellis Pharmaceutical Consulting, Inc., Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844180 is the FDA 510(k) clearance record for THE MCP-70-SE SYSTEM, a class II device, cleared for Ellis Pharmaceutical Consulting, Inc. on under FDA product code KQA (Device, Beam Limiting, X-Ray, Therapeutic). FDA records list 5 510(k) clearances for Ellis Pharmaceutical Consulting, Inc., from to . As of , FDA records show no recalls naming K844180.

Clearance record

Decision date
Received
(98 days to decision)
Product code
KQA Device, Beam Limiting, X-Ray, Therapeutic
Regulation
21 CFR 892.5900
Device class
Class II
Review panel
Radiology
Applicant
Ellis Pharmaceutical Consulting, Inc. 913 State Rd., Princeton NJ
Third party review
No

Clearances, product code KQA

Trailing 12 months

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

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