AUTOMATIC POSITIVE BEAM COLLIMATOR

Device, Beam Limiting, X-ray, Diagnostic

DIAL-X INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Dial-x Instruments, Inc. with the FDA for Automatic Positive Beam Collimator.

Pre-market Notification Details

Device IDK791504
510k NumberK791504
Device Name:AUTOMATIC POSITIVE BEAM COLLIMATOR
ClassificationDevice, Beam Limiting, X-ray, Diagnostic
Applicant DIAL-X INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKPW  
CFR Regulation Number892.1610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-08-06
Decision Date1979-09-07

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