Bi-N

FDA 510(k) K924828 · Xre Corp.

Substantially Equivalent

510(k) numberK924828

Submission

Device name
Bi-N
Applicant
Xre Corp.
Littleton, MA, US
Received
September 28, 1992
Decision date
December 17, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IZI – System, X-Ray, Angiographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1600
Specialty
Radiology

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More from Surgvision GmbH

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K973744Unicath SP Bi-Plane (Model M269 & M289)JAA · Traditional 12/29/1997SE
K961193Full Frame Zoom SystemJAA · Traditional 06/17/1996SE
K960998Xre CollimatorIZW · Traditional 04/03/1996SE
K945449Unicath Llu Angiographic SystemIZI · Traditional 02/27/1995SE
K936002Cinemac QasIZI · Traditional 09/09/1994SE
K933460DVFX, Model M256IZI · Traditional 04/07/1994SE
K923654Poly Diagnost CDXIZI · Traditional 11/20/1992SE
K913685Unicath Ep.IZI · Traditional 11/07/1991SE
K912416Angiographic or Fluoroscopic X-Ray SystemIZI · Traditional 08/28/1991SE
K892849Unicath aIZI · Traditional 08/09/1989SE

Questions and answers

When was Bi-N cleared by the FDA?

Bi-N (K924828) received a 510(k) decision of Substantially Equivalent on December 17, 1992, 80 days after the submission was received.

What is the product code of K924828?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.