Csp-A (Ceiling Suspended Positioner-Angio)

Q: What is the product code of K924137?

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

FDA 510(k) K924137 · Fischer Imaging Corp.

Substantially Equivalent

510(k) numberK924137

Submission

Device name: Csp-A (Ceiling Suspended Positioner-Angio)
Applicant: Fischer Imaging Corp.
Denver, CO, US
Received: August 18, 1992
Decision date: December 28, 1992
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary 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

Other 510(k)s with product code IZI

510(k)	Device	Applicant	Decision
K261037	780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional	Stryker Endoscopy	05/28/2026SE
K253181	SURGIMAGE SIM 1000H Fluorescence Imaging PlatformIZI · Traditional	Surgimage Corporation	05/13/2026SE
K243645	IC-Flow Imaging System 2.0IZI · Traditional	Diagnostic Green GmbH	09/22/2025SE
K243077	Affirm 800IZI · Traditional	Digital Surgery Systems, Inc. (D.B.A True…	06/27/2025SE
K231986	Modus IRIZI · Traditional	Synaptive Medical, Inc.	03/25/2024SE
K234090	EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)IZI · Traditional	Surgvision GmbH	03/20/2024SE
K231075	Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)IZI · Traditional	Carl Zeiss Meditec, Inc.	06/20/2023SE
K230727	SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional	Novadaq Technologies Ulc (A Part of Stryker)	06/05/2023SE
K222240	Explorer Air® IIIZI · Traditional	Surgvision GmbH	02/28/2023SE
K214097	Explorer Air IIIZI · Traditional	Surgvision GmbH	02/25/2022SE

More from Surgvision GmbH

510(k)	Device	Decision
K042095	MammotestIZH · Traditional	10/29/2004SE
K021113	MammopathMWP · Traditional	06/13/2002SE
K981414	LC PositionerJAA · Traditional	07/16/1998SE
K973400	Mammotest Adapter DriverIZH · Traditional	11/10/1997SE
K964806	MD-1835IXL · Traditional	03/04/1997SE
K961207	Ep-X BiplaneJAA · Traditional	08/20/1996SE
K961022	Tangent Vi TableIXR · Traditional	05/03/1996SE
K950291	Digital 625HFIZO · Traditional	03/23/1995SE
K945619	Athena HFXIZH · Traditional	03/23/1995SE
K944150	Micro X-65 HFIZO · Traditional	09/16/1994SE

Questions and answers

When was Csp-A (Ceiling Suspended Positioner-Angio) cleared by the FDA?

Csp-A (Ceiling Suspended Positioner-Angio) (K924137) received a 510(k) decision of Substantially Equivalent on December 28, 1992, 132 days after the submission was received.

What is the product code of K924137?

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