Cleared Traditional

K982795 - PHILIPS BUCKY VISION

K982795 is the FDA 510(k) clearance for PHILIPS BUCKY VISION by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (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

Submission Details

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.

Device Classification

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 218
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K982795.
FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
K993861 · Fujifilm Medical System U.S.A., Inc. · Feb 2000
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22
K992547 · Canon USA, Inc. · Oct 1999
THORAX FD AND MULTIX FD
K983732 · Siemens Medical Solutions USA, Inc. · Apr 1999
CANON X-RAY DIGITAL CAMERA CXDI-11
K981556 · Canon USA, Inc. · Nov 1998