Cleared Traditional

K954705 - ACRYSTEEL BLOCKING TRAY

K954705 is an FDA 510(k) clearance for ACRYSTEEL BLOCKING TRAY, manufactured by Medtec, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K954705 · Medtec, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
85d
Days
Class 2
Risk

K954705 is an FDA 510(k) clearance for the ACRYSTEEL BLOCKING TRAY. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 85 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 Medtec, Inc. devices

FDA 510(k) Submission Details - K954705

510(k) Number K954705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date January 05, 1996
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

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 548
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K954705.
COMPUTE-RX PLAN PC3D
K953508 · Medicalibration Physics Consultant Services, Inc. · Feb 1996
VARIAN MULTILEAF COLLIMATOR
K943224 · Varian Assoc., Inc. · Feb 1996
EXL-12SP & 12DP LINAC
K952314 · Mitsubishi Intl. Corp. · Jan 1996
PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)
K940001 · Nucletron Corp. · Nov 1995
PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP)
K953570 · Philips Medical Systems, Inc. · Oct 1995
PAINTED WEDGE & ROD BREAST BOARD
K952729 · Medtec, Inc. · Sep 1995