Cleared Traditional

K883161 - HIMOBILIX 2N

K883161 is an FDA 510(k) clearance for HIMOBILIX 2N, manufactured by Bay X-Ray, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K883161 · Bay X-Ray, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1988
Decision
87d
Days
Class 2
Risk

K883161 is an FDA 510(k) clearance for the HIMOBILIX 2N. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Bay X-Ray, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on October 21, 1988 after a review of 87 days - a notably fast clearance cycle.

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: 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 Bay X-Ray, Inc. devices

FDA 510(k) Submission Details - K883161

510(k) Number K883161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1988
Decision Date October 21, 1988
Days to Decision 87 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 107d · This submission: 87d
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 194
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K883161.
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
SHIMADZU LATERAL C-ARM MH-31
K882311 · Shimadzu Precision Instruments, Inc. · Sep 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