The Omega Medical Imaging, Inc. e-VIEW systems are intended for use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

Device Description

The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.

AI/ML Overview

This 510(k) summary for the Omega Medical Imaging e-VIEW radiographic/fluoroscopy system does not contain the detailed study information typically found in a clinical trial report or a comprehensive performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with safety standards.

Therefore, many of the requested categories regarding acceptance criteria and study particulars cannot be directly answered from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (as implied or stated)	Reported Device Performance (as stated or implied)
Safety Compliance	Compliance with 21 CFR 1020.30	The e-VIEW systems will comply with these requirements.
	Compliance with 21 CFR 1020.31	The e-VIEW systems will comply with these requirements.
	Compliance with 21 CFR 1020.32	The e-VIEW systems will comply with these requirements.
	Compliance with IEC 60601-1	The e-VIEW systems will comply with this standard.
	Compliance with IEC 60101-1-2	The e-VIEW systems will comply with this standard.
	Compliance with IEC 60601-1-3	The e-VIEW systems will comply with this standard.
	Compliance with IEC 60601-2-7	The e-VIEW systems will comply with this standard.
	Compliance with IEC 60601-2-28	The e-VIEW systems will comply with this standard.
	Compliance with IEC 60601-2-32	The e-VIEW systems will comply with this standard.
	Compliance with UL 60601-1	The e-VIEW systems will comply with this standard.
	Compliance with CAN/USA C22.2 No.601.1-M90	The e-VIEW systems will comply with this standard.
Intended Use Equivalence	Use in radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.	The e-VIEW systems are intended for use in these applications, demonstrating equivalence to predicate devices which also serve these purposes.
Hazard Equivalence	No new indications for use.	Stated: "The Omega e-VIEW systems do not introduce any new indications for use."
	No new potential hazards.	Stated: "nor does the use of the device result in any new potential hazard."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. This document is a 510(k) summary focusing on substantial equivalence through technical and regulatory compliance, not a clinical study report with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set with ground truth established by experts is mentioned in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Not done. This device is an X-ray system, not an AI-powered diagnostic tool, and there's no mention of a human-in-the-loop study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Not done. This refers to a medical imaging device itself, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. There is no mention of ground truth in the context of diagnostic performance studies. The "ground truth" implied for safety and performance is adherence to established engineering standards and equivalence to predicate devices.

8. The sample size for the training set

Not applicable. No machine learning model or training set is discussed.

9. How the ground truth for the training set was established

Not applicable. No machine learning model or training set is discussed.

Summary of the Study (as described in the 510k summary):

The "study" presented here is not a clinical trial in the traditional sense, but rather a demonstration of substantial equivalence to previously cleared predicate devices. The methodology relies on:

Comparative Analysis: The Omega e-VIEW system's design, intended use, and technical specifications are compared to those of the Siemens AXIOM ARTIS U Angiography System (K040675), Philips Integris H5000 Angiography System (K984545), and Omega Medical Imaging B200/C300 Fluoroscopy System (K902005). The conclusion is that the e-VIEW systems "do not introduce any new indications for use, nor does the use of the device result in any new potential hazard."
Compliance with Recognized Standards: The primary "acceptance criteria" and "proof" presented are commitments to comply with a comprehensive list of FDA regulations (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32) and international safety standards (IEC 60601-1 series, UL 60601-1, CAN/USA C22.2 No.601.1-M90). This compliance serves as evidence that the device meets safety and basic performance expectations.

In essence, the submission asserts that because the e-VIEW system is designed to meet established safety standards and performs functions equivalent to existing, legally marketed devices, it can be considered safe and effective without requiring new clinical performance studies.

Summary

{0}------------------------------------------------

K062647

OMEGA MEDICAL IMAGING, INC.

510(k) SUMMARY

	Company Name:
Address:	675 Hickman CircleSanford, FL 32771	OCT 20 2006
Telephone No:	407-323-9400
Registration No.:	1052701
Contact person:	James A. Princehorn
Date Prepared:	14 April 2006
Device (trade) name:	e-VIEW radiographic/fluoroscopy system
Classification Name:	Angiographic X-ray System
Classification Panel:	Radiology
CFR Section:	892.1650 and 892.1600
Device Class:	Class II
Device Code:	DWB & JAA
Common/usual name:	System, X-Ray, Fluoroscopic, Image-Intensified

Predicate device(s):

Siemens AXIOM ARTIS U Angiography System (K040675) ●
Philips Integris H5000 Angiography System (K984545) .
Omega Medical Imaging B200/C300 Fluoroscopy System (K902005). .

Device description:

The Omega Medical Imaging, Inc. e-VIEW systems are comprised of an x-ray source/image � receptor positioning device in a permanently floor mounted C-Arm configuration. The positioning of the source/receptor is schieved by motorized motions controlled by the operator. The patient table can be configured with different motorized motions including elevating, Trendelenburg and vertical tilt, lateral and longitudinal table top travel, and lateral table top tilt. The imaging is achieved by way of an image intensifier/CCD camera with digitty in nage processing.

Intended use:

. The Omega Medical Imaging, e-VIEW systems are Inc. intended for use in radiographic/fluoroscopic applications including cardiac. vascular. general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

{1}------------------------------------------------

Safety information:

The Omega e-VIEW systems will comply with the applicable requirements of 21 CFR 1020.30, . 21 CFR 1020.31, and 21 CFR 1020.32.
The Omega e-VIEW systems will comply with the international safety standards IEC 60601-1. . IEC 60101-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, and IEC 60601-2-32 .
The Omega e-VIEW systems will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .

Conclusion:

The Omega e-VIEW systems do not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Omega considers the e-VIEW systems to be substantially equivalent with the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

FEB 1 9 2013

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771

Re: K062647

Trade/Device Name: e-VIEW Fluoroscopy System Model CS-50 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: August 31, 2006 Received: August 6, 2006

Dear Mr. Princehorn:

This letter corrects our substantially equivalent letter of October 20, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

{3}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number: K 062647

Device Name: e-VIEW Fluoroscopy System, Model CS-50

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

David A. Ingram
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices K062647
510(k) Number

Omegs Medical Imaging e-VIEW 510(k)

Section I

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.