Cleared Traditional

K904986 - PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K904986 · Perkins Mfg. Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
32d
Days
Class 2
Risk

K904986 is an FDA 510(k) clearance for the PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Perkins Mfg. Co. (Dallas, US). The FDA issued a Cleared decision on December 4, 1990 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Perkins Mfg. Co. devices

Submission Details

510(k) Number K904986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1990
Decision Date December 04, 1990
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 298
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K904986.
Insight Enhanced™ DRF (EN-1002-01)
K251650 · Imaging Engineering, LLC · Sep 2025
Soteria E-View
K242488 · Omega Medical Imaging, LLC · Jan 2025
Adora DRFi (04550010)
K242948 · Nrt X-Ray A/S · Dec 2024
TRIDENT Mobile Fluoroscopy System
K233380 · Dornier Medtech America · Jun 2024
ProxiDiagnost N90 / Precision CRF (706110, 706400)
K233945 · Philips Medical Systems Dmc GmbH · Jan 2024
CombiDiagnost R90
K232910 · Philips Medical Systems Dmc GmbH · Oct 2023