TXR 325 X-Ray Control with High Voltage Generator

FDA 510(k) K860203 · Tingle X-Ray Products, Inc.

Substantially Equivalent

510(k) numberK860203

Submission

Device name
TXR 325 X-Ray Control with High Voltage Generator
Applicant
Tingle X-Ray Products, Inc.
Vance, AL, US
Received
January 22, 1986
Decision date
January 30, 1986
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

More from Scott Imaging Intl., Inc.

510(k)DeviceDecision
K926554525 SFQ X-Ray Control W/High Voltage GeneratorKPR · Traditional 05/17/1993SE
K930249Bc/Wt/PfIXY · Traditional 04/27/1993SE

Questions and answers

When was TXR 325 X-Ray Control with High Voltage Generator cleared by the FDA?

TXR 325 X-Ray Control with High Voltage Generator (K860203) received a 510(k) decision of Substantially Equivalent on January 30, 1986, 8 days after the submission was received.

What is the product code of K860203?

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