DART-12

FDA 510(k) K052705 · Direx Systems Corp.

Substantially Equivalent

510(k) numberK052705

Submission

Device name
DART-12
Applicant
Direx Systems Corp.
Natick, MA, US
Received
September 28, 2005
Decision date
February 21, 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
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was DART-12 cleared by the FDA?

DART-12 (K052705) received a 510(k) decision of Substantially Equivalent on February 21, 2006, 146 days after the submission was received.

What is the product code of K052705?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.