STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY

Solid State X-ray Imager (flat Panel/digital Imager)

STERLING DIAGNOSTIC IMAGING, INC.

The following data is part of a premarket notification filed by Sterling Diagnostic Imaging, Inc. with the FDA for Sterling Diagnostic Imaging Direct Radiography.

Pre-market Notification Details

Device IDK973206
510k NumberK973206
Device Name:STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark,  DE  19714 -6101
ContactElaine H Kindell
CorrespondentElaine H Kindell
STERLING DIAGNOSTIC IMAGING, INC. P.O. BOX 6101 BUILDING 600/MAILBOX 630 Newark,  DE  19714 -6101
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-26
Decision Date1997-12-04
Summary:summary

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