Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard

System, X-ray, Stationary

Radmedix LLC

The following data is part of a premarket notification filed by Radmedix Llc with the FDA for Acuity Sdr Standard, Acuity Sdr Plus, Acuity Fdr Standard.

Pre-market Notification Details

Device IDK193360
510k NumberK193360
Device Name:Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
ClassificationSystem, X-ray, Stationary
Applicant Radmedix LLC 2510 Lance Dr. Dayton,  OH  45409
ContactGabriel Issa
CorrespondentDaniel Kamm
Kamm & Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-04
Decision Date2020-01-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810035220041 K193360 000
00810035220317 K193360 000
00810035220324 K193360 000
00810035220065 K193360 000
00810035220072 K193360 000
00810035220089 K193360 000
00810035220096 K193360 000
00810035220102 K193360 000
00810035220058 K193360 000
00810035220003 K193360 000
00810035220010 K193360 000
00810035220027 K193360 000
00810035220034 K193360 000
00810035220454 K193360 000

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