Cleared Traditional

K961484 - CASS SYSTEM (MODIFICATION)

K961484 is an FDA 510(k) clearance for CASS SYSTEM (MODIFICATION), manufactured by Medical Instrumentation & Diagnostics Corp.(Midco). The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K961484 · Medical Instrumentation & Diagnostics Corp.(Midco) · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
223d
Days
Class 2
Risk

K961484 is an FDA 510(k) clearance for the CASS SYSTEM (MODIFICATION). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medical Instrumentation & Diagnostics Corp.(Midco) (San Diego, US). The FDA issued a Cleared decision on November 7, 1996 after a review of 223 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - 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 Medical Instrumentation & Diagnostics Corp.(Midco) devices

FDA 510(k) Submission Details - K961484

510(k) Number K961484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1996
Decision Date November 07, 1996
Days to Decision 223 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 107d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 - IYE Accelerator, Linear, Medical

All 441
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K961484.
PEACOCK SYSTEM
K963258 · Nomos Corp. · Nov 1996
LINAC SCALPEL TREATMENT PLANNING SYSTEM
K962792 · Surgical Navigation Technologies, Inc. · Nov 1996
THERAPLAN PLUS
K954679 · Theratronics, Inc. · Nov 1996
BREAST TREATMENT AID M200
K962487 · S. and H. Engineering, Inc. · Sep 1996
RPS-50 BEAM SCANNER
K962080 · Sofield Science Services, Inc. · Aug 1996
GILL-THOMAS-COSMAN(GTC) DENTAL TRAY
K962155 · Radionics Software Applications, Inc. · Aug 1996