Cleared Traditional

K983678 - ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE

K983678 is an FDA 510(k) clearance for ELEKTA ONCOLOGY SYSTEMS PRECISE TREATME..., manufactured by Elekta Instruments, Inc.. The device is a Class 2 Radiology device with product code JAI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K983678 · Elekta Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
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Jan 1999
Decision
87d
Days
Class 2
Risk

K983678 is an FDA 510(k) clearance for the ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE. Classified as Couch, Radiation Therapy, Powered (product code JAI), Class II - Special Controls.

Submitted by Elekta Instruments, Inc. (Norcross, US). The FDA issued a Cleared decision on January 15, 1999 after a review of 87 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 Elekta Instruments, Inc. devices

FDA 510(k) Submission Details - K983678

510(k) Number K983678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1998
Decision Date January 15, 1999
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 12
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