Cleared Traditional

K971382 - PRONE BREAST POSITIONING BOARD

K971382 is the FDA 510(k) clearance for PRONE BREAST POSITIONING BOARD by Victoreen, Inc.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K971382 · Victoreen, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
84d
Days
Class 2
Risk

K971382 is an FDA 510(k) clearance for the PRONE BREAST POSITIONING BOARD, MODEL #37-018. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Victoreen, Inc. (Solon, US). The FDA issued a Cleared decision on June 6, 1997 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Victoreen, Inc. devices

Submission Details

510(k) Number K971382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1997
Decision Date June 06, 1997
Days to Decision 84 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
23d faster than avg
Panel avg: 107d · This submission: 84d
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 327
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K971382.
CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM
K962950 · Varian Medical Systems, Inc. · Jul 1997
NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2
K964206 · Nucletron Corp. · Jun 1997
VERIDOSE DIODES
K964785 · Victoreen, Inc. · Jun 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
K970291 · Elekta Instrument AB · Apr 1997
LINAC SCALPEL FLOORSTAND
K964517 · Surgical Navigation Technologies, Inc. · Apr 1997
PHILIPS SLI SERIES LINEAR ACCELERATOR
K963624 · Philips Medical Systems, Inc. · Dec 1996