Cleared Traditional

K970291 - ACCESSORIES TO THE STEREOTACTIC BODY FRAM

K970291 is the FDA 510(k) clearance for ACCESSORIES TO THE STEREOTACTIC BODY FRAM by Elekta Instrument AB. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K970291 · Elekta Instrument AB · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
90d
Days
Class 2
Risk

K970291 is an FDA 510(k) clearance for the ACCESSORIES TO THE STEREOTACTIC BODY FRAM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Elekta Instrument AB (Linkoping, SE). The FDA issued a Cleared decision on April 24, 1997 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 892.5050 - 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: 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 Elekta Instrument AB devices

Submission Details

510(k) Number K970291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1997
Decision Date April 24, 1997
Days to Decision 90 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
17d faster than avg
Panel avg: 107d · This submission: 90d
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 303
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K970291.
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM
K962950 · Varian Medical Systems, Inc. · Jul 1997
VERIDOSE DIODES
K964785 · Victoreen, Inc. · Jun 1997
PRONE BREAST POSITIONING BOARD, MODEL #37-018
K971382 · Victoreen, Inc. · Jun 1997
PHILIPS SLI SERIES LINEAR ACCELERATOR
K963624 · Philips Medical Systems, Inc. · Dec 1996
KODAK EC-L CASSETTE
K960834 · Eastman Kodak Company · May 1996
STEREOTACTIC BODY FRAME
K960338 · Elekta Instrument AB · Apr 1996