Cleared Traditional

K943602 - DI-2000

K943602 is an FDA 510(k) clearance for DI-2000, manufactured by Miles Inc., Agfa Division. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 291-day FDA review.

K943602 · Miles Inc., Agfa Division · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
291d
Days
Class 1
Risk

K943602 is an FDA 510(k) clearance for the DI-2000. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Miles Inc., Agfa Division (Ridgefield Park, US). The FDA issued a Cleared decision on May 12, 1995 after a review of 291 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Inc., Agfa Division devices

FDA 510(k) Submission Details - K943602

510(k) Number K943602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1994
Decision Date May 12, 1995
Days to Decision 291 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 107d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

IYX Device Classification - Class 1, General Controls

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 89
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K943602.
LUMAGEM SCINTILLATION CAMERA
K993813 · Gamma Medica · Jan 2000
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
K984466 · Dilon Technologies, Inc. · Mar 1999
NOTEBOOK IMAGER
K961104 · Digirad Corp. · May 1997
APEX SPX CARDIAL
K932673 · Elscint, Inc. · Feb 1994
CARBON FIBER PALLET
K934766 · Siemens Gammasonics, Inc. · Feb 1994
R &D BATTERIES, INC. PART # 5015, 5192, 5482
K933513 · R & D Batteries, Inc. · Nov 1993