Bladderscan Bvi 9400 Ultrasound

Q: What is the product code of K071217?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.

FDA 510(k) K071217 · Verathon Incorporated

Substantially Equivalent

510(k) numberK071217

Submission

Device name: Bladderscan Bvi 9400 Ultrasound
Applicant: Verathon Incorporated
Bothell, WA, US
Received: May 2, 2007
Decision date: May 17, 2007
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: IYO – System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1560
Specialty: Radiology

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K243227	B-ScanIYO · Traditional	Accutome, Inc. Doing Business AS Keeler USA	07/11/2025SE

More from Accutome, Inc. Doing Business AS Keeler USA

510(k)	Device	Decision
K172356	BladderScan Prime PLUS SystemIYO · Traditional	09/15/2017SE
K153101	BladderScan Prime SystemIYO · Traditional	11/19/2015SE
K090214	Verathon Inc. Bladderscan BVM 9500 UltrasoundIYO · Abbreviated	03/13/2009SE
K082456	Verathon Inc. Bladderscan Ultrasound System, Model Bvi 9600IYO · Abbreviated	12/01/2008SE

Questions and answers

When was Bladderscan Bvi 9400 Ultrasound cleared by the FDA?

Bladderscan Bvi 9400 Ultrasound (K071217) received a 510(k) decision of Substantially Equivalent on May 17, 2007, 15 days after the submission was received.

What is the product code of K071217?

The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.