Cleared Traditional

PROCESSING SYSTEM, A2 IMAGE (K782047) - FDA 510(k) Clearance

Class I Radiology device.

K782047 · Medtronic Vascular · Radiology device

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Dec 1978

Decision

12d

Days

Class 1

Risk

K782047 is an FDA 510(k) clearance for the PROCESSING SYSTEM, A2 IMAGE. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on December 20, 1978 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - 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 Medtronic Vascular devices

Submission Details

510(k) Number	K782047 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 08, 1978
Decision Date	December 20, 1978
Days to Decision	12 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

95d faster than avg

Panel avg: 107d · This submission: 12d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	IYX Camera, Scintillation (gamma)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 892.1100

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 129

Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K782047.

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3D-RD-S

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UNIX-LINK

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STARPORT MODEL H3300AA

K852648 · General Electric Co. · Jan 1986

TOMOGRAPHIC GANTRY

K844218 · General Electric Co. · Mar 1985

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K782047

Medtronic Vascular

Walker, MI · US

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Radiology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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