Ilook 25 Needle Guide Attachment and Bracket Assembly

Q: What is the product code of K030064?

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

FDA 510(k) K030064 · Sonosite,Inc.

Substantially Equivalent

510(k) numberK030064

Submission

Device name: Ilook 25 Needle Guide Attachment and Bracket Assembly
Applicant: Sonosite,Inc.
Bothell, WA, US
Received: January 7, 2003
Decision date: January 22, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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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K101757	Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemITX · Traditional	08/12/2010SE
K092058	Sonosite Nanomaxx Series Ultrasound SystemIYN · Traditional	10/02/2009SE
K082098	Sonosite Maxx Series Ultrasound SystemIYN · Traditional	08/25/2008SE
K071134	Sonosite Maxx Series Diagnostic Ultrasound SystemIYO · Traditional	05/08/2007SE
K053069	Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)IYN · Traditional	11/16/2005SE
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Questions and answers

When was Ilook 25 Needle Guide Attachment and Bracket Assembly cleared by the FDA?

Ilook 25 Needle Guide Attachment and Bracket Assembly (K030064) received a 510(k) decision of Substantially Equivalent on January 22, 2003, 15 days after the submission was received.

What is the product code of K030064?

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