ARC-600

FDA 510(k) K933100 · B C Medical , Ltd.

Substantially Equivalent

510(k) numberK933100

Submission

Device name
ARC-600
Applicant
B C Medical , Ltd.
J3y 7p9, CA
Received
June 24, 1993
Decision date
November 8, 1993
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

510(k)DeviceDecision
K946378BCM 400CPIZI · Traditional 05/04/1995SE
K933035BCM-600TXKPX · Traditional 10/08/1993SE
K920862BCM-400CIZI · Traditional 09/30/1992SE
K890306Bcm-Arc 105 X-Ray Mobile UnitIZL · Traditional 04/17/1989SE
K870205Rotax-Ii Bi-Plane Circular Arm · Traditional 03/06/1987SE
K801950BCM-600 Mini-Six Extra Lg. Field AngioKPX · Traditional 10/03/1980SE
K801949BCM-302 Collimating Cone & CompensatinJZW · Traditional 10/03/1980SE

Questions and answers

When was ARC-600 cleared by the FDA?

ARC-600 (K933100) received a 510(k) decision of Substantially Equivalent on November 8, 1993, 137 days after the submission was received.

What is the product code of K933100?

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