Cleared Traditional

AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER (K990997) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K990997 · Aktina Medical Physics Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
89d
Days
Class 2
Risk

K990997 is an FDA 510(k) clearance for the AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Aktina Medical Physics Corp. (Congers, US). The FDA issued a Cleared decision on June 22, 1999 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aktina Medical Physics Corp. devices

Submission Details

510(k) Number K990997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1999
Decision Date June 22, 1999
Days to Decision 89 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
18d faster than avg
Panel avg: 107d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 203
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K990997.
PORTALVISION
K003636 · Varian Medical Systems, Inc. · Feb 2001
VARIS 1.4G
K001643 · Varian Medical Systems, Inc. · Jun 2000
PRIMUS
K993425 · Siemens Medical Solutions USA, Inc. · Nov 1999
GENESIS IMRT LINEAR ACCELERATOR
K982502 · Siemens Medical Solutions USA, Inc. · Jul 1998
MX MEVATRON
K982513 · Siemens Medical Solutions USA, Inc. · Jul 1998
VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE
K973889 · Varian Medical Systems, Inc. · Nov 1997