Cleared Traditional

K982795 - PHILIPS BUCKY VISION

K982795 is an FDA 510(k) clearance for PHILIPS BUCKY VISION, manufactured by Philips Medical Systems, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K982795 · Philips Medical Systems, Inc. · Radiology device
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Nov 1998
Decision
106d
Days
Class 2
Risk

K982795 is an FDA 510(k) clearance for the PHILIPS BUCKY VISION. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on November 24, 1998 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Philips Medical Systems, Inc. devices

FDA 510(k) Submission Details - K982795

510(k) Number K982795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1998
Decision Date November 24, 1998
Days to Decision 106 days
Submission Type Traditional
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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 398
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K982795.
KONICA DIRECT DIGITIZER, MODEL DD-341
K990359 · Konica Corp. · Aug 1999
THORAX FD AND MULTIX FD
K983732 · Siemens Medical Solutions USA, Inc. · Apr 1999
CDR - PAN MODEL 4700
K982661 · Schick Technologies, Inc. · Dec 1998
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556 · Canon USA, Inc. · Nov 1998
STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
K973206 · Sterling Diagnostic Imaging, Inc. · Dec 1997