Selector MD (50KW and 80 KW)

FDA 510(k) K910650 · Hofmann-Nagel Medical Systems, Inc.

Substantially Equivalent

510(k) numberK910650

Submission

Device name
Selector MD (50KW and 80 KW)
Applicant
Hofmann-Nagel Medical Systems, Inc.
Irvine, CA, US
Received
February 14, 1991
Decision date
June 6, 1991
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 Selector MD (50KW and 80 KW) cleared by the FDA?

Selector MD (50KW and 80 KW) (K910650) received a 510(k) decision of Substantially Equivalent on June 6, 1991, 112 days after the submission was received.

What is the product code of K910650?

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