Cleared Traditional

K001295 - PIPER

K001295 is an FDA 510(k) clearance for PIPER, manufactured by Rtek Medical Systems, LLC. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K001295 · Rtek Medical Systems, LLC · Radiology device
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Oct 2000
Decision
184d
Days
Class 2
Risk

K001295 is an FDA 510(k) clearance for the PIPER. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by Rtek Medical Systems, LLC (Pittsford, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 184 days - an extended review 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: 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 Rtek Medical Systems, LLC devices

FDA 510(k) Submission Details - K001295

510(k) Number K001295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2000
Decision Date October 25, 2000
Days to Decision 184 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 107d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
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 - MUJ System, Planning, Radiation Therapy Treatment

All 208
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K001295.
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K010784 · Nucletron Corp. · Apr 2001
P3IMRT TM
K002237 · Adac Laboratories · Feb 2001
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · Brainlab AG · Nov 2000
FOCUS
K002147 · Computerized Medical Systems, Inc. · Oct 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · Nomos Corp. · Sep 2000
PROTON VISION 7.0
K002312 · Varian Medical Systems, Inc. · Aug 2000