Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105

Q: What is the product code of K961690?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.

FDA 510(k) K961690 · Continental X-Ray Corp.

Substantially Equivalent

510(k) numberK961690

Submission

Device name: Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105
Applicant: Continental X-Ray Corp.
Broadview, IL, US
Received: May 1, 1996
Decision date: June 27, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1650
Specialty: Radiology

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More from Omega Medical Imaging, LLC

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K972442	Ceiling Mounted Lateral Positioner, Model No. 6896.002JAA · Traditional	09/11/1997SE
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K954581	Arc SeriesIZI · Traditional	12/21/1995SE
K950571	Linear FR Tomographic System: 0MT 8000, Model No. 6681.270IZF · Traditional	03/31/1995SE
K942175	Linear Tomographic System: PMT 6000IZF · Traditional	08/17/1994SE
K942100	Model TM Ep High Voltage GeneratorIZO · Traditional	06/07/1994SE
K934686	Molybdenum/Rhodium FiltersIZO · Traditional	05/26/1994SE
K931724	Electrophysiology (Ep) Table Ep 2000 SeriesKXJ · Traditional	06/14/1993SE
K925934	Wall Bucky Holders Lt. & Rt. Hand, & Center MountIXY · Traditional	03/04/1993SE
K921986	Patient Information Manager (Pim)IZH · Traditional	10/16/1992SE

Questions and answers

When was Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105 cleared by the FDA?

Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105 (K961690) received a 510(k) decision of Substantially Equivalent on June 27, 1996, 57 days after the submission was received.

What is the product code of K961690?

The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.