Cleared Traditional

K993522 - AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT

K993522 is an FDA 510(k) clearance for AKTINA MEDICAL PHYSICS CORPORATION TENN..., manufactured by Aktina Medical Physics Corp.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K993522 · Aktina Medical Physics Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
84d
Days
Class 2
Risk

K993522 is an FDA 510(k) clearance for the AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Aktina Medical Physics Corp. (Congers, US). The FDA issued a Cleared decision on January 10, 2000 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5770 - 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

FDA 510(k) Submission Details - K993522

510(k) Number K993522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date January 10, 2000
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAI Device Classification - Class 2, Special Controls

Product Code JAI Couch, Radiation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5770
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 - JAI Couch, Radiation Therapy, Powered

All 10
Devices cleared under the same product code (JAI) and FDA review panel - the closest regulatory comparables to K993522.
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