TEC1410 Anatomical Programming Generator-Modificat

FDA 510(k) K922814 · Bay Shore Medical Equipment Corp.

Substantially Equivalent

510(k) numberK922814

Submission

Device name
TEC1410 Anatomical Programming Generator-Modificat
Applicant
Bay Shore Medical Equipment Corp.
Bay Shore, NY, US
Received
June 2, 1992
Decision date
September 11, 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
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
K904397Tec 1410IZO · Traditional 11/13/1990SE
K892342Tec 2750 Phoenix Dedicated Mammographic SystemIZH · Traditional 11/17/1989SE

Questions and answers

When was TEC1410 Anatomical Programming Generator-Modificat cleared by the FDA?

TEC1410 Anatomical Programming Generator-Modificat (K922814) received a 510(k) decision of Substantially Equivalent on September 11, 1992, 101 days after the submission was received.

What is the product code of K922814?

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