Cleared Traditional

K052067 - DOPPLER GUIDED PROCTOSCOPE, MODEL 500H

K052067 is an FDA 510(k) clearance for DOPPLER GUIDED PROCTOSCOPE, manufactured by Multigon Industries, Inc.. The device is a Class 2 Radiology device with product code JAF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K052067 · Multigon Industries, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
28d
Days
Class 2
Risk

K052067 is an FDA 510(k) clearance for the DOPPLER GUIDED PROCTOSCOPE, MODEL 500H. Classified as Monitor, Ultrasonic, Nonfetal (product code JAF), Class II - Special Controls.

Submitted by Multigon Industries, Inc. (Yonkers, US). The FDA issued a Cleared decision on August 29, 2005 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1540 - 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 Multigon Industries, Inc. devices

FDA 510(k) Submission Details - K052067

510(k) Number K052067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date August 29, 2005
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAF Device Classification - Class 2, Special Controls

Product Code JAF Monitor, Ultrasonic, Nonfetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1540
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 - JAF Monitor, Ultrasonic, Nonfetal

All 19
Devices cleared under the same product code (JAF) and FDA review panel - the closest regulatory comparables to K052067.
Laminar P1 (LDH-HW-001)
K242487 · Laminar Digital Health, Inc. · Dec 2024
SIMPLEABI
K110628 · Newman Medical · May 2011
CAREDOP II
K982635 · Nicolet Biomedical · Aug 1998
IMEX STETHODOP
K973336 · Imex Medical Systems, Inc. · Feb 1998
FLOSTAT VASCULAR REPORT GENERATOR (VRG)
K973857 · Biomedix, Inc. · Dec 1997
FLOSTAT VASCULAR LAB
K973644 · Biomedix, Inc. · Dec 1997