Cleared Special

K120388 - INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM

K120388 is an FDA 510(k) clearance for INSIGHT - FD MINI C-ARM FLUOROSCOPIC IM..., manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Special 510(k) pathway after a 59-day FDA review.

K120388 · Hologic, Inc. · Radiology device
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Apr 2012
Decision
59d
Days
Class 2
Risk

K120388 is an FDA 510(k) clearance for the INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on April 6, 2012 after a review of 59 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K120388

510(k) Number K120388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2012
Decision Date April 06, 2012
Days to Decision 59 days
Submission Type Special
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
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 64
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