Cleared Traditional

K992794 - STINGRAY DR, MODEL 1

K992794 is an FDA 510(k) clearance for STINGRAY DR, manufactured by Infimed, Inc.. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K992794 · Infimed, Inc. · Radiology device
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Nov 1999
Decision
82d
Days
Class 2
Risk

K992794 is an FDA 510(k) clearance for the STINGRAY DR, MODEL 1. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Infimed, Inc. (Liverpool, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 82 days - a notably fast clearance cycle.

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: 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 Infimed, Inc. devices

FDA 510(k) Submission Details - K992794

510(k) Number K992794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1999
Decision Date November 09, 1999
Days to Decision 82 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 107d · This submission: 82d
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 295
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K992794.
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · Fujifilm Medical System U.S.A., Inc. · Dec 2001
ADC PEDIATRIC
K012750 · Agfa Corp. · Nov 2001
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
PHILIPS BUCKY VISION
K982795 · Philips Medical Systems, Inc. · Nov 1998