Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013714596

FEI Number

3013714596

Entity Name

BIOKINEMETRICS INC.

City/State/Country

Carroll, IA, US

Establishment Address

211 E. 4th St., Carroll, IA 51401, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biokinemetrics, Inc. (Owner Number: 10050908)

Owner / Operator Contact Address

211 E. 4th St., PO Box 276, Carroll, IA 51401, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092307

PMA Number

N/A

All Registered Proprietary Names

BIOK7600 Flat Panel Detector ChiroSight Flat Panel Detector and Software ChiroSight BIOK7600 Flat Panel Detector and Software ChiroSight BIOK7600W Wireless Flat Panel Detector ChiroSight ChiroSight Wireless Flat Panel Detector and Software ChiroSight BIOK7600W Wireless Flat Panel Detector and Software IMA-4600 BIOK4600 ChiroSight BIOK4600 Detector and Software ChiroSight Detector and Software

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-04-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-04-10
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2016-01-15

Official Correspondent

Steven Kraus

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biokinemetrics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015	Siemens Medical Solutions USA, Inc	2	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.

Similar Registrations

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3003775006	FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office	HANAMAKI-SHI Iwate, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013714596. Last updated year: 2026. Please use registration number 3013714596 when referencing this establishment in official correspondence.