Cleared Special

K983088 - INSTACINE D-2000

K983088 is an FDA 510(k) clearance for INSTACINE D-2000, manufactured by Fidelity Medical, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 25-day FDA review.

K983088 · Fidelity Medical, Inc. · Radiology device
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Sep 1998
Decision
25d
Days
Class 2
Risk

K983088 is an FDA 510(k) clearance for the INSTACINE D-2000. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Fidelity Medical, Inc. (Fairfield, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Fidelity Medical, Inc. devices

FDA 510(k) Submission Details - K983088

510(k) Number K983088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1998
Decision Date September 22, 1998
Days to Decision 25 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 107d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1328
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K983088.
ULTRAPRO MODEL 98
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DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)
K982120 · Trex Medical Corp. · Sep 1998
PEDIATRIC INSTATRAK SYSTEM
K981998 · Visualization Technology, Inc. · Aug 1998