Cleared Traditional

K893644 - PK2025/PK2045 PROGRAMMABLE VIDEO CONTRO...

K893644 is the FDA 510(k) clearance for PK2025/PK2045 PROGRAMMABLE VIDEO CONTRO... by Perkins Mfg. Co.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K893644 · Perkins Mfg. Co. · Radiology device
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Aug 1989
Decision
86d
Days
Class 2
Risk

K893644 is an FDA 510(k) clearance for the PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER. 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 August 9, 1989 after a review of 86 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 K893644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 09, 1989
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
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 136
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K893644.
DIGIFORMER HR DFP-50A
K901405 · Toshiba America Medical Systems, In.C · May 1990
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895394 · Shimadzu Corp. · Nov 1989
DA-100HS
K894913 · Fischer Imaging Corp. · Sep 1989
DIGITAL SPOT IMAGING (DSI)
K893131 · Philips Medical Systems, Inc. · Jun 1989
UNIVERSAL ABC CONTROLER
K883580 · Philips Medical Systems (Cleveland), Inc. · Jan 1989
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · Medrad, Inc. · Dec 1988