The intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.

Device Description

The Horizon® Series Imagers are dry, thermal, grey scale (Gs model) and grey scale/color (Ci model) direct thermal printer/imagers. The devices produce continuous tone, diagnostic quality B/W images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality.

AI/ML Overview

This document describes the Codonics Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA PRINTERS (Horizon® Ci and Gs Medical Multimedia Dry Imagers). These devices are dry, thermal printer/imagers designed to produce continuous tone, diagnostic quality B/W images on transmissive film and reflective media, and color images via dye-diffusion technology. They are intended for high-resolution hard copy imaging from various medical imaging modalities for medical image diagnosis and referral.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit, quantitative acceptance criteria in a table format with corresponding reported performance metrics for diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, it describes performance characteristics related to image quality and substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Image Fidelity / Diagnostic Quality	"The devices produce continuous tone, diagnostic quality B/W images on transmissive film and reflective incident light viewed media. The color images produced via dye-diffusion technology are photographic medical color matched quality."
Spatial Resolution	Pixel size: 79µ, resulting in a pixel resolution of 12.6 pixels/mm or 320 dpi.
Grey Scale Resolution	Produces a palate of 4096 levels of discernable grey. The SMPTE resolution and contrast pattern and uniform density response function confirms quality suitable for the intended medical imaging use.
Color Palate Resolution	Produces 256 levels of 16.7 million colors.
Modulation Transfer Function (overall image quality)	Spatial frequency response, grey scale resolution, density response, and full image field uniformity combine to affect the final image. Characteristic response of thermal print head and film response must be mapped and compensated for to achieve suitable performance. The SMPTE resolution and contrast pattern and uniform density response function confirms quality suitable for the intended medical imaging use.
Safety and Effectiveness (Substantial Equivalence)	"The characteristics of the Horizon® Series Imagers compare substantially to the Codonics NP-1660 Series Medical Printers (K003481), FUJI FM-DP 2636 Dry Imager (K962967), AGFA DryStar Models 3000 & 4500M (K012941), and Seiko ColorPoint 1720 (K991282) in system function and intended uses."
Electrical Compliance and Electromagnetic Standards	Passed a series of electrical safety tests including UL 2601-1, CAN/CSA-C22.2 No 601.1-M90, IEC EN-60601-1, TUV/EN-60950:1992 and EN 60950/A1:1993. Complies with electromagnetic standards defined in EN-60601-1-2.
Data Integrity (Interpolation and Scaling)	"Interpolation and scaling of images without Lossy data compression is employed in this device to maintain data integrity."
Validated Linear Routines & Look Up Tables (LUTs)	"Validated digital linear and visual linear routines and verified industry/modality specific Look Up Tables (LUTs) are applied to optimize color and CRT image hardcopy display results."
Hazard Analysis (Level of Concern)	Hazard analysis concluded that potential hazards are not different from other multiformat hardcopy image components, primarily related to computer system component failure, not expected to materially contribute to patient death or injury. Concluded "level of Concern" is "Minor".

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "clinical studies" but does not specify the sample size of a test set (e.g., number of images or cases) used for clinical evaluation of diagnostic performance. The provenance of this data (e.g., country of origin, retrospective or prospective) is also not provided. The focus of the reported "clinical studies" appears to be on verifying effective application and consistent results with predicate devices, rather than a diagnostic accuracy study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The study design described does not involve establishing ground truth for a diagnostic test set in the conventional sense of a clinical diagnostic study for sensitivity/specificity.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance attributes. There is no information about how much human readers improve with or without AI assistance, as this is a medical printer, not an AI-driven diagnostic aid.

6. Standalone (Algorithm Only) Performance Study

As this device is a medical hardcopy printer, the concept of a "standalone (algorithm only)" performance study for diagnostic accuracy is not directly applicable. The "algorithm" here refers to image processing for printing, not a diagnostic algorithm. The performance described (e.g., pixel resolution, grey scale levels) relates to the output quality of the printed image itself.

7. Type of Ground Truth Used

The document does not describe the use of a formal diagnostic ground truth (e.g., pathology, outcomes data, expert consensus) tied to a specific diagnostic performance study. The "clinical studies" mentioned seem to verify the functionality and consistency of the printed output compared to existing devices. The "ground truth" for evaluating the printer's performance refers to physical image quality metrics (e.g., SMPTE pattern resolution, density response, color matching) and consistency with predicate device output.

8. Sample Size for the Training Set

This information is not applicable. The device is a printer that processes images based on established algorithms and look-up tables, not a machine learning algorithm that requires a "training set" in the context of AI/ML models for diagnostic tasks.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Codonics. The logo consists of a stylized hexagon shape with a small line segment above it on the left side, followed by the word "CODONICS" in bold, sans-serif font. Below the word "CODONICS" is the tagline "We bring the future into focus" in a smaller, italicized font.

KO2/054

510(k) Summary

807.92(c) 807.92(a)(1)

Submitter Information: て
- 1.1 Submitter:

Codonics, Inc. 17991 Englewood Drive Middleburg Heights, Ohio 44130

1 . 2Manufacturing Facility:

Same as above

1.3Representative:

Not applicable at this time

1.4Contact:

Gary W. Enos, Phone:(440) 243-1198 / Fax : (440) 243-1334 17991 Englewood Drive Middleburg Heights, Ohio 44130

1.5Date: March 15, 2002

2 Device Name

807.92(a)(2) & 807.92(a)(3)

2.1 Camera, Multiformat, Radiological

2.2 Classification Name:	Medical Image Hardcopy Devices
Classification Number:	892.2040
2.3 Classification Code:	LMC
2.4Trade/Proprietary Name:	Horizon® Series MEDICAL IMAGE HARDCOPYMULTIMEDIA PRINTERS: Horizon® Ci and Gs MedicalMultimedia Dry Imagers

Codonics NP-1660 Series Medical Printers (Premarket 2.5 Predicate Devices: notification K003481) and AGFA DryStar Models 3000 & 4500M (Premarket notification K012941)

Device Description 3

807.92(a)(4)

3.1 Function

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3.2Scientific Concepts:

Digital images input directly or via Local Area Network is managed via communication i standards including however not limited to FTP, TCP/IP, and DICOM. Images of a variety of digital formats are managed via industry standard format conversion software and image rendering algorithms including however not limited to TIFF, GIF, PCX, BMP, PBM, PGM, PPM, XWD, JPEG, SunRaster, SGI, Targa, DICOM, DEFF, and Postscript. Interpolation and scaling of images without Lossy data compression is employed in this device to maintain data integrity. Validated digital linear and visual linear routines and verified industry/modality specific Look Up Tables (LUTs) are applied to optimize color and CRT image hardcopy display results.

Imaging is accomplished via directly-modulated discrete-element thin-layer linear thermal print head technology. The recording medium is either heat sensitive silver in the case of DV grey scale film and DV DirectView reflective record imaging, or thermal heat activated dye-diffusion of color in the case of CV DirectView and Transparency/film record imaging. The action of heat on the grey scale media produces a black dye in the medium. The action of heat on the dye-diffusion media produces a precision mixing of colors, which diffuse the medium top layer. The image formation is accomplished without wet chemistry processing common to many laser film imaging systems in use today.

3.3Physical And Performance Characteristics:

In the case of medical image hard copy devices, important performance characteristics, which affect the effectiveness and safety, relate to the fidelity of the modulation transfer function. Spatial frequency response, grey scale resolution, density response and full image field uniformity combine to affect the final image. Characteristic response of thermal print head and film response must be mapped and compensated for to achieve suitable performance.

Pixel size (79µ for the Horizon® Series Imagers) produces a pixel resolution of 12.6 pixels/mm or 320 dpi. The grey scale resolution produces a palate of 4096 levels of discernable grey, while the color palate produces 256 levels of 16.7 millions colors. The SMPTE resolution and contrast pattern and uniform density response function confirms quality suitable for the intended medical imaging use.

4 Device Intended Use:

807.92(a)(5)

4.1 The intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of direct/indirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.

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Device Technological Characteristics: 807.92(a)(6) 5

5.1 The characteristics of the Horizon® Series Imagers compare substantially to the Codonics NP-1660 Series Medical Printers (Premarket notification K003481), FUJI FM-DP 2636 Dry Imager (Premarket notification K962967), AGFA DryStar Models 3000 & 4500M (Premarket notification K012941), and Seiko ColorPoint 1720 (Premarket notification K991282) in system function and intended uses. The technology and applications are substantially equivalent to models of printers already cleared to market by the FDA, with the added convenience of combining multi-sized color and grey scale film and reflective media. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category.

Testing and Equivalence: 807.92(b)(1), 807.92(b)(2) & 807.92(b)(3) 6

6.1 In the code implementation, electrical compliance tests, simulation, printer resolution pattern testing, and clinical studies, results and outcomes have been thoroughly reviewed with proper operation and intended functions verified. The device passed a series of electrical safety tests including UL 2601-1, CAN/CSA-C22.2 No 601.1-M90, IEC EN-60601-1, TUV/EN-60950:1992 and EN 60950/A1:1993. The devices comply with electromagnetic standards defined in EN-60601-1-2. Clinical tests have documented effective application and expected results consistent with predicate devices currently in commercial distribution.
Codonics believes the Horizon® Series Imagers to be substantially equivalent to Medical Image Hardcopy Devices currently in commercial distribution in the U.S. We have selected the Codonics NP-1660 Series Medical Printers (Premarket notification K003481) and AGFA DryStar Models 3000 & 4500M (Premarket notification K012941) as the predicate devices for our claim of substantial equivalence, Attachment 6 contains information describing these predicate devices and provides a comparison of the Horizon® Series Imagers to the predicate device(s) and describes how any differences of note are substantially equivalent.

7 Hazard Analysis and Safety Concerns

7.1Hazard analysis on this product has been performed throughout the definition, design, and testing phases of the product development and implementation. This process has emphasized:

Identification of potential hazards, their causes and their effects .
. Development of methodologies to control the occurrence of hazards and to constrain their effects;
. Determine any effect on patient safety and system effectiveness

The potential hazards associated with this software product are not different than those of other multiformat hardcopy image components. These are primarily related to the failure of computer system components, and may be variously obviated by decisions taken by the end users of the product. None of the failures are expected to materially contribute to patient death or injury.

It is our conclusion that no hardware or software component, operating in a properly configured environment, whose latent design defect would be expected to result in death or injury of the patient. Thus the "level of Concern" is "Minor".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

MAY 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary W. Enos Director, New Business Development Codonics. Inc. 17991 Englewood Drive MIDDLEBURG HEIGHTS OH 44130

Re: K021054

Trade/Device Name: Codonics Horizon® Ci Medical Multimedia Dry Imager Condonics Horizon® Gs Medical Multimedia Grey Scale Dry Imager Regulation Number: 21 CFR 892.2040 Regulation Name: Medical Image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: March 27, 2002 Received: April 1, 2002

Dear Mr. Enos

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Ko2/0554

Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA Device Name: PRINTERS

Horizon® Ci Color and Grey Scale Multimedia Imager Models: Horizon® Gs Grey Scale Multimedia Imager

Indications For Use:

The intended uses of the Horizon® Series Imagers is high resolution hard copy imaging of digital image source material and through the conversion of electronic signals from a wide variety of directlindirect medical imaging modality outputs. The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning. Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians.

The intended uses are identical to the Codonics NP-1660 Series Medical Printers (Premarket notification K003481) as a combined color, film, reflective media imager. The intended uses are identical to the FUJI FM-DP 2636 Dry Imager (Premarket notification K962967) and AGFA DryStar Model 4500M ((Premarket notification K012941) in terms of dry radiological output devices with the addition of 14 x 17 media formats.

(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) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C. bogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021054

Regulation Number and Section

§ 892.2040 Medical image hardcopy device.

(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.