Aspen Ultrasound with Freestyle Imaging Option

Q: What is the product code of K991805?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.

FDA 510(k) K991805 · Acuson Corp.

Substantially Equivalent

510(k) numberK991805

Submission

Device name: Aspen Ultrasound with Freestyle Imaging Option
Applicant: Acuson Corp.
Mountain View, CA, US
Received: May 26, 1999
Decision date: August 2, 1999
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: IYN – System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1550
Specialty: Radiology

Other 510(k)s with product code IYN

510(k)	Device	Applicant	Decision
K261313	Vivid Explorer/Vivid Advanced/Vivid FocusIYN · Traditional	GE Medical Systems Ultrasound and Primary Care…	09/02/2026SE
K254027	Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90…IYN · Traditional	Sonoscape Medical Corp.	08/24/2026SE
K261668	Venue GoIYN · Traditional	GE Medical Systems Ultrasound and Primary care…	08/07/2026SE
K262311	Alturion Series Diagnostic Ultrasound SystemIYN · Special	Philips Ultrasound, LLC	08/04/2026SE
K261835	LOGIQ FocusIYN · Traditional	GE Medical Systems Ultrasound and Primary Care…	07/30/2026SE
K261288	Handheld Ultrasound ScannerIYN · Traditional	Imgfax Co., Ltd.	07/30/2026SE
K261412	V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System…IYN · Traditional	Samsung Medison Co., Ltd.	07/28/2026SE
K261211	Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic…IYN · Traditional	Philips Ultrasound, LLC	07/27/2026SE
K261272	ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/…IYN · Traditional	Esonic Technology (Wuhan) Co., Ltd.	07/23/2026SE
K261081	Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)IYN · Special	Beijing Konted Medical Technology Co.,Ltd	07/23/2026SE

More from Beijing Konted Medical Technology Co.,Ltd

510(k)	Device	Decision
K023772	Kinetdx Picture Archiving and Communications SystemLLZ · Traditional	11/22/2002SE
K022896	CSV12 Software ViewerLLZ · Special	10/03/2002SE
K022567	Sequoia Signature II Diagnostic Ultrasound SystemIYN · Traditional	08/13/2002SE
K021497	Cypress Ultrasound SystemIYN · Special	07/09/2002SE
K010950	Cypress SystemIYO · Abbreviated	06/27/2001SE
K002807	3D Organ Assessment W/ Magnetic Position SensingIYO · Traditional	12/01/2000SE
K992631	Acunav Diagnostic Ultrasound CatheterDQO · Traditional	12/15/1999SE
K992580	Fetal Assessment CapIYO · Traditional	10/18/1999SE
K973767	Harmonic Imaging with ContrastIYO · Traditional	12/23/1997SE
K973079	L7 Transducer Used on Aspen Model Ultrasound SystemITX · Traditional	11/05/1997SE

Questions and answers

When was Aspen Ultrasound with Freestyle Imaging Option cleared by the FDA?

Aspen Ultrasound with Freestyle Imaging Option (K991805) received a 510(k) decision of Substantially Equivalent on August 2, 1999, 68 days after the submission was received.

What is the product code of K991805?

The FDA product code is IYN – System, Imaging, Pulsed Doppler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1550.