Cleared Traditional

K953227 - CASPER

K953227 is an FDA 510(k) clearance for CASPER, manufactured by Northwest Medical Physics Center. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K953227 · Northwest Medical Physics Center · Radiology device
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Nov 1995
Decision
140d
Days
Class 2
Risk

K953227 is an FDA 510(k) clearance for the CASPER. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Northwest Medical Physics Center (Lynnwood, US). The FDA issued a Cleared decision on November 22, 1995 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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 Northwest Medical Physics Center devices

FDA 510(k) Submission Details - K953227

510(k) Number K953227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1995
Decision Date November 22, 1995
Days to Decision 140 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 37
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K953227.
SATURNE MULTILEAF COLLIMATOR
K970303 · General Electric Co. · Apr 1997
SIEMENS BEAM SHAPER
K961902 · Siemens Medical Solutions USA, Inc. · Aug 1996
SIEMENS VIRTURAL WEDGE
K954248 · Siemens Medical Solutions USA, Inc. · Jan 1996
SIEMENS MULTILEAF COLLIMATOR
K953894 · Siemens Medical Solutions USA, Inc. · Nov 1995
MULTILEAF INTENSITY MODULATING COLLIMATOR
K940412 · Nomos Corp. · Feb 1995
FIELD ABUTMENT WEDGE
K943343 · Medtec, Inc. · Dec 1994