Accu-Source

FDA 510(k) K051753 · Oncology Systems, Inc.

Substantially Equivalent

510(k) numberK051753

Submission

Device name
Accu-Source
Applicant
Oncology Systems, Inc.
Champaign, IL, US
Received
June 29, 2005
Decision date
March 29, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAQ – System, Applicator, Radionuclide, Remote-Controlled
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5700
Specialty
Radiology

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Questions and answers

When was Accu-Source cleared by the FDA?

Accu-Source (K051753) received a 510(k) decision of Substantially Equivalent on March 29, 2006, 273 days after the submission was received.

What is the product code of K051753?

The FDA product code is JAQ – System, Applicator, Radionuclide, Remote-Controlled, a Class II (moderate risk) device regulated under 21 CFR 892.5700.