Cleared Special

K051025 - FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCO...

K051025 is the FDA 510(k) clearance for FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCO... by Hologic, Inc.. It is a Class 2 Radiology device (product code JAA) cleared through the Special 510(k) pathway after a 21-day FDA review.

K051025 · Hologic, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
21d
Days
Class 2
Risk

K051025 is an FDA 510(k) clearance for the FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on May 13, 2005 after a review of 21 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

Submission Details

510(k) Number K051025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2005
Decision Date May 13, 2005
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 135
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K051025.
PRECISION 500D R&F X-RAY SYSTEM
K081091 · Ge Healthcare · Jun 2008
PRECISION THUNIS 800+
K061028 · Ge Medical Systems, LLC · Jun 2006
SMITH & NEPHEW CDS SYSTEM
K051136 · Smith & Nephew, Inc. · Jul 2005
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
K040870 · Shimadzu Corp. · May 2004
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K021021 · Siemens Medical Solutions USA, Inc. · Jun 2002
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
K020055 · Philips Medical Systems · Mar 2002