ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE— 510(k) K983678

Name: FDA 510(k) clearance K983678
Creator: U.S. Food and Drug Administration
Published: 1999-01-15

Substantially Equivalent

Elekta Instruments, Inc.

FDA 510(k) clearance K983678 for ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE, Substantially Equivalent on 1999-01-15. Applicant: Elekta Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Elekta Instruments, Inc.
Product code: Code JAI
Device class: Class 2
Regulation: 21 CFR 892.5770
Advisory panel: Radiology
Date received: 1998-10-20
Decision date: 1999-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norcross, GA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K983678

K-number listed on FDA's recall record

Z-1238-2015 — Elekta Precise Treatment TableClass II·Terminated·Elekta, Inc.·20150129
Z-1072-2013 — Precise Treatment Table. To be used as part of radiation therapy treatment process.Class II·Terminated·Elekta, Inc.·20130314

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983678.

Data sourced from openFDA. This site is unofficial and independent of the FDA.