510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974239Substantially Equivalent

Aktina Medical Physics Corporation Photon Beam Blocking System

Aktina Medical Physics Corp., Congers NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974239 is the FDA 510(k) clearance record for AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM, a class II device, cleared for Aktina Medical Physics Corp. on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 13 510(k) clearances for Aktina Medical Physics Corp., from to . As of , FDA records show no recalls naming K974239.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
Aktina Medical Physics Corp. 360 N. Rte. 9w, Congers NY
510(k) summary
Summary
Third party review
No

Clearances, product code IXI

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