Cleared Traditional

K925598 - BUCKYMATIC AUTOMATIC CHEST FILM CHANGER

K925598 is an FDA 510(k) clearance for BUCKYMATIC AUTOMATIC CHEST FILM CHANGER, manufactured by Acoma Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code KPX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K925598 · Acoma Medical Imaging, Inc. · Radiology device
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Feb 1993
Decision
88d
Days
Class 2
Risk

K925598 is an FDA 510(k) clearance for the BUCKYMATIC AUTOMATIC CHEST FILM CHANGER. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on February 1, 1993 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1860 - 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.

FDA 510(k) Submission Details - K925598

510(k) Number K925598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1992
Decision Date February 01, 1993
Days to Decision 88 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
19d faster than avg
Panel avg: 107d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPX Device Classification - Class 2, Special Controls

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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 - KPX Changer, Radiographic Film/cassette

All 18
Devices cleared under the same product code (KPX) and FDA review panel - the closest regulatory comparables to K925598.
ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES
K935157 · Regulatory Consultants TO the Medical Device Indus · Aug 1994
NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS
K934850 · Victoreen, Inc. · Nov 1993
BCM-600TX
K933035 · B C Medical , Ltd. · Oct 1993
MWX-7440 HIGH SPEED BUCKY
K924423 · Midwest X-Ray Equipment Co. · Jan 1993
SHIMADZU RADIOGRAPJHIC STAND BR-100
K925169 · Shimadzu Medical Systems · Dec 1992
OX-600
K920196 · Stardard X-Ray Sales Co. · Oct 1992
K925598 · BUCKYMATIC AUTOMATIC CHEST FILM CHANGER
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