Versaboard, Model 7040

Q: What is the product code of K030051?

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

FDA 510(k) K030051 · Bionix Development Corp.

Substantially Equivalent

510(k) numberK030051

Submission

Device name: Versaboard, Model 7040
Applicant: Bionix Development Corp.
Toledo, OH, US
Received: January 6, 2003
Decision date: April 4, 2003
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 Versaboard, Model 7040 cleared by the FDA?

Versaboard, Model 7040 (K030051) received a 510(k) decision of Substantially Equivalent on April 4, 2003, 88 days after the submission was received.

What is the product code of K030051?

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