BR 2002 X-Ray Generator System

FDA 510(k) K801808 · Valmet Indus. Mach. & Prod., Inc.

Substantially Equivalent

510(k) numberK801808

Submission

Device name
BR 2002 X-Ray Generator System
Applicant
Valmet Indus. Mach. & Prod., Inc.
Mchenry, IL, US
Received
July 30, 1980
Decision date
September 26, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZO – Generator, High-Voltage, X-Ray, Diagnostic
Device class
Class I (low risk)
Regulation
21 CFR 892.1700
Specialty
Radiology

Other 510(k)s with product code IZO

510(k)DeviceApplicantDecision
K954666MPH50, MPH65, and MPH80IZO · Traditional GE Medical Systems11/24/1995SE
K953582HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray GeneratorIZO · Traditional Varian Canada, Inc.09/26/1995SE
K953831N 800 HFIZO · Traditional Nucletron-Oldelft Corp.09/08/1995SE
K952822Shimadzu X-Ray High Viltage Generator AHD150GIZO · Traditional Shimadzu Corp.07/12/1995SE
K952265Milestonw 350/450/550HF, PCX N350/450/550HF, Top-X 350/450/550HF Radiographic X-Ray…IZO · Traditional Control-X, Inc.07/06/1995SE
K950883Polydoros SX 65 and 80IZO · Traditional Siemens Medical Solutions USA, Inc.04/03/1995SE
K950694Compact-XIZO · Traditional Electromed Intl., Ltd.03/31/1995SE
K950291Digital 625HFIZO · Traditional Fischer Imaging Corp.03/23/1995SE
K950041Sii 360 AprIZO · Traditional Scott Imaging Intl., Inc.03/21/1995SE
K950040Sii 525 AprIZO · Traditional Scott Imaging Intl., Inc.03/21/1995SE

Questions and answers

When was BR 2002 X-Ray Generator System cleared by the FDA?

BR 2002 X-Ray Generator System (K801808) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 58 days after the submission was received.

What is the product code of K801808?

The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.