ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE

Couch, Radiation Therapy, Powered

ELEKTA INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Elekta Instruments, Inc. with the FDA for Elekta Oncology Systems Precise Treatment Table.

Pre-market Notification Details

Device IDK983678
510k NumberK983678
Device Name:ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
ClassificationCouch, Radiation Therapy, Powered
Applicant ELEKTA INSTRUMENTS, INC. 3155 NORTHWOODS PKWY. N.W. Norcross,  GA  30071
ContactPaul L Sumner
CorrespondentPaul L Sumner
ELEKTA INSTRUMENTS, INC. 3155 NORTHWOODS PKWY. N.W. Norcross,  GA  30071
Product CodeJAI  
CFR Regulation Number892.5770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-20
Decision Date1999-01-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060191071086 K983678 000

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