Cleared Traditional

K910384 - VIDEO ANNOTATOR MODEL PK2310

K910384 is an FDA 510(k) clearance for VIDEO ANNOTATOR MODEL PK2310, manufactured by Perkins Mfg. Co.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K910384 · Perkins Mfg. Co. · Radiology device
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Apr 1991
Decision
77d
Days
Class 2
Risk

K910384 is an FDA 510(k) clearance for the VIDEO ANNOTATOR MODEL PK2310. 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 April 16, 1991 after a review of 77 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.

FDA 510(k) Submission Details - K910384

510(k) Number K910384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1991
Decision Date April 16, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K910384.
PHILIPS DIAGNOST 96
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LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380 · Siemens Medical Solutions USA, Inc. · Jul 1991
FC2000
K911454 · S & S Inficon, Inc. · Jul 1991
STS(TM) FLUOROSCOPIC IMAGING MODULE
K905278 · Medstone Intl., Inc. · Feb 1991
DIGITAL DISK RECORDER(DDR) W/NUMERICAL SUFFIXES
K905111 · Eigen · Jan 1991
PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060
K904986 · Perkins Mfg. Co. · Dec 1990
K910384 · VIDEO ANNOTATOR MODEL PK2310
Download PDF Perkins Mfg. Co.