Cleared Traditional

K942504 - INSTASPOT

K942504 is an FDA 510(k) clearance for INSTASPOT, manufactured by Fidelity Medical, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K942504 · Fidelity Medical, Inc. · Radiology device
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May 1995
Decision
344d
Days
Class 2
Risk

K942504 is an FDA 510(k) clearance for the INSTASPOT. 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. (Florham Park, US). The FDA issued a Cleared decision on May 5, 1995 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate-to-high equivalence dependency. 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.

FDA 510(k) Submission Details - K942504

510(k) Number K942504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date May 05, 1995
Days to Decision 344 days
Submission Type Traditional
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
237d slower than avg
Panel avg: 107d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2268
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K942504.
CEMAX VIPSTATION AND/OR SOFTWARE
K945188 · Cemax, Inc. · Aug 1995
COMPUSPEAK
K941566 · Hogan & Hartson · Jun 1995
WITT BIOMEDICAL IMAGE III
K945582 · Witt Biomedical Corporation · Jun 1995
SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION
K945428 · Multi-Dimensional Imaging, Inc. · Mar 1995
MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)
K946117 · Siemens Medical Solutions Health Services Corporat · Mar 1995
IVR MASTER
K945389 · Shimadzu Corp. · Feb 1995
K942504 · INSTASPOT
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