Ameritek Brachytherapy Template

FDA 510(k) K011581 · Amertek Medical, Inc.

Substantially Equivalent

510(k) numberK011581

Submission

Device name
Ameritek Brachytherapy Template
Applicant
Amertek Medical, Inc.
Singer Island, FL, US
Received
May 23, 2001
Decision date
July 17, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITX – Transducer, Ultrasonic, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

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Questions and answers

When was Ameritek Brachytherapy Template cleared by the FDA?

Ameritek Brachytherapy Template (K011581) received a 510(k) decision of Substantially Equivalent on July 17, 2001, 55 days after the submission was received.

What is the product code of K011581?

The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.