Cleared Traditional

K980526 - PHOTON RADIOSURGERY SYSTEM PRS400

K980526 is an FDA 510(k) clearance for PHOTON RADIOSURGERY SYSTEM PRS400, manufactured by Pec Photoelectron Corp.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K980526 · Pec Photoelectron Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
167d
Days
Class 2
Risk

K980526 is an FDA 510(k) clearance for the PHOTON RADIOSURGERY SYSTEM PRS400. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Pec Photoelectron Corp. (Lexington, US). The FDA issued a Cleared decision on July 27, 1998 after a review of 167 days - an extended review 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: 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 Pec Photoelectron Corp. devices

FDA 510(k) Submission Details - K980526

510(k) Number K980526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1998
Decision Date July 27, 1998
Days to Decision 167 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
60d slower than avg
Panel avg: 107d · This submission: 167d
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 20
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K980526.
INTRABEAM 600
K162568 · Carl Zeiss Meditec, AG · Dec 2016
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
K130549 · Carl Zeiss Meditec, Inc. · Jun 2013
INTRABEAM SYSTEM WITH INTRABEAM SPHERICAL APPLICATORS
K121653 · Carl Zeiss Meditec, Inc. · Dec 2012
THERAPAX DXT 300 MODEL HF-300
K973315 · Pantak, Inc. · Dec 1997
VERIDOSE V (FIVE), MODEL NUMBER 37-705
K964952 · Victoreen, Inc. · Jul 1997
PHOTON RADIOSURGERY SYSTEM (PRS)
K964947 · Photoelectron Corporation · Jun 1997