Cleared Traditional

DFI-1000 AND DVS-475 IMAGING DEVICES (K951261) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951261 · Nical · Radiology device
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Mar 1996
Decision
360d
Days
Class 2
Risk

K951261 is an FDA 510(k) clearance for the DFI-1000 AND DVS-475 IMAGING DEVICES. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Nical (Dobbs Ferry, US). The FDA issued a Cleared decision on March 15, 1996 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Nical devices

Submission Details

510(k) Number K951261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date March 15, 1996
Days to Decision 360 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
253d slower than avg
Panel avg: 107d · This submission: 360d
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 72
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K951261.
TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.)
K993038 · Toshiba America Medical Systems, In.C · Oct 1999
CAREGRAPH
K982319 · Siemens Medical Solutions USA, Inc. · Sep 1998
FLUOROSPOT COMPACT
K982028 · Siemens Medical Solutions USA, Inc. · Jul 1998
SIREGRAPH CF
K960266 · Siemens Medical Solutions USA, Inc. · Mar 1996
MAX-1000A/R1
K954590 · Toshiba America Medical Systems, In.C · Nov 1995
FLUOREX DTA-400A
K946081 · Toshiba America Medical Systems, In.C · May 1995