Cleared Traditional

K945039 - MCI OPTONIX CASSETTE OKAMOTO CASSETE

K945039 is an FDA 510(k) clearance for MCI OPTONIX CASSETTE OKAMOTO CASSETE, manufactured by Mci Optonix, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K945039 · Mci Optonix, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
39d
Days
Class 2
Risk

K945039 is an FDA 510(k) clearance for the MCI OPTONIX CASSETTE OKAMOTO CASSETE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Mci Optonix, Inc. (Cedar Knolls, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1850 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mci Optonix, Inc. devices

FDA 510(k) Submission Details - K945039

510(k) Number K945039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date November 22, 1994
Days to Decision 39 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
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXA Device Classification - Class 2, Special Controls

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 36
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K945039.
RADIOGRAPHIC FILM CASSETTES
K962336 · Unidex Group, Inc. · Jul 1996
CRONEX RADIATION THERAPY CASSETTE
K953724 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995
CRONEX RADIATION THERAPY VERIFICATION CASSETTE
K953725 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1995
MT-300 CASSETTE HOLDER
K941600 · Medtec, Inc. · Sep 1994
FUJI ULTIMA EC-MA CASSETTE
K942481 · Fujifilm Medical System U.S.A., Inc. · Jul 1994
CRONEX REGULAR CASSETTE
K941475 · Dupont Medical Products · Jul 1994