Cleared Traditional

K974239 - AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM

K974239 is an FDA 510(k) clearance for AKTINA MEDICAL PHYSICS CORPORATION PHOT..., manufactured by Aktina Medical Physics Corp.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974239 · Aktina Medical Physics Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
90d
Days
Class 2
Risk

K974239 is an FDA 510(k) clearance for the AKTINA MEDICAL PHYSICS CORPORATION PHOTON BEAM BLOCKING SYSTEM. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Aktina Medical Physics Corp. (Congers, US). The FDA issued a Cleared decision on February 10, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aktina Medical Physics Corp. devices

FDA 510(k) Submission Details - K974239

510(k) Number K974239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date February 10, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IXI Block, Beam-shaping, Radiation Therapy

All 19
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K974239.
MICROMLC
K032790 · Siemens Medical Solutions USA, Inc. · Oct 2003
ENHANCED COMPENSATING FILTER
K000137 · Computerized Medical Systems, Inc. · Apr 2000
ANGIO-CT MIYABI
K990491 · Siemens Medical Solutions USA, Inc. · Apr 1999
AKTINA MEDICAL PHYSICS CORPORATION EECTRON BEAM FIELD SHAPING SYSTEM
K973953 · Aktina Medical Physics Corp. · Jan 1998
AUTIMO 2.5-D AND AUTIMO 3-D
K972016 · C.L. Mcintosh & Assoc., Inc. · Dec 1997
AUTIMO
K971001 · Medizintechnik, GmbH · Jun 1997