Cleared Traditional

K992577 - PHOTON RADIOSURGERY SYSTEM (PRS)

K992577 is an FDA 510(k) clearance for PHOTON RADIOSURGERY SYSTEM (PRS), manufactured by Photoelectron Corporation. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K992577 · Photoelectron Corporation · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
52d
Days
Class 2
Risk

K992577 is an FDA 510(k) clearance for the PHOTON RADIOSURGERY SYSTEM (PRS). Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Photoelectron Corporation (Lexington, US). The FDA issued a Cleared decision on September 23, 1999 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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.

FDA 510(k) Submission Details - K992577

510(k) Number K992577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1999
Decision Date September 23, 1999
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 43
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K992577.
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K992577 · PHOTON RADIOSURGERY SYSTEM (PRS)
Download PDF FDA Summary Photoelectron Corpora…