Cleared Traditional

K882311 - SHIMADZU LATERAL C-ARM MH-31

K882311 is an FDA 510(k) clearance for SHIMADZU LATERAL C-ARM MH-31, manufactured by Shimadzu Precision Instruments, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K882311 · Shimadzu Precision Instruments, Inc. · Radiology device
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Sep 1988
Decision
103d
Days
Class 2
Risk

K882311 is an FDA 510(k) clearance for the SHIMADZU LATERAL C-ARM MH-31. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Shimadzu Precision Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on September 14, 1988 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Shimadzu Precision Instruments, Inc. devices

FDA 510(k) Submission Details - K882311

510(k) Number K882311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1988
Decision Date September 14, 1988
Days to Decision 103 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 107d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 149
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K882311.
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · Medrad, Inc. · Dec 1988
ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K883372 · Ausonics Pty , Ltd. · Nov 1988
CARDIAC CX
K883985 · Fischer Imaging Corp. · Nov 1988
CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K880527 · Fischer Imaging Corp. · Feb 1988
REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K874901 · Fischer Imaging Corp. · Jan 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50A
K875157 · Shimadzu Precision Instruments, Inc. · Jan 1988