ACCULMAING

K102849 · Radiology Information Systems, Inc. · LLZ · Nov 23, 2010 · Radiology

Device Facts

• Record ID: K102849
• Device Name: ACCULMAING
• Applicant: Radiology Information Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Acculmaging is a software module capable of taking an X-ray image generated by a CR or DR and producing a digitally enhanced image for projection radiography applications. Acculmaging is not indicated for use in mammography.

Device Story

Acculmaging is a Dynamic Link Library (DLL) software module designed for integration into radiological imaging applications running on Microsoft Windows. It receives raw X-ray image data (raster format) from CR or DR systems as input. The device applies image processing algorithms—including noise reduction, Perceptual Tone Scale (PTS) mapping, high-frequency band-pass wavelet filtering for edge enhancement, and Enhanced Visualization Processing (EVP)—to optimize diagnostic quality. The processed output is provided to the parent application for display to radiologists. Used in radiology departments and medical imaging centers, the device assists clinicians by enhancing image detail and reducing the need for manual image manipulation. It does not provide a user interface and functions as a background service within a larger imaging workflow.

Clinical Evidence

No clinical testing data submitted. Bench testing consisted of a comparative expert review of eight image sets, evaluating diagnostic quality and feature detail equivalence against the predicate device.

Technological Characteristics

Software-only module (DLL). Implements image processing algorithms: noise reduction (weighted average/median filtering), Perceptual Tone Scale (PTS) mapping, high-frequency band-pass wavelet filtering for edge enhancement, and Enhanced Visualization Processing (EVP) with DC component suppression. Operates within Microsoft Windows environment. Integrated into parent radiological applications. No hardware components.

Indications for Use

Indicated for projection radiography applications using X-ray images generated by CR or DR systems. Not indicated for use in mammography.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*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).

Predicate Devices

• Eclipse Image Processing Software (K060137)

Submission Summary (Full Text)

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# 510(k) SUMMARY

K102849

NOV 2 3 2010

This 510(k) Summary provides the following information, in accordance with 21 CFR 807.92.

#### SUBMITTER'S INFORMATION [21 CFR 807.92(a)(1)]

Radiology Information Systems, Inc. (RADinfo SYSTEMS) 43676 Trade Center Place, Suite 100 Dulles, VA 20166 Prepared on September 27, 2010 Contact Person: E.J. Smith President, Smith Associates (Consultant to Submitter) 1468 Harwell Ave. Crofton, MD 21114

Phone: [phone]

#### DEVICE NAME [21 CFR 807.92(a)(2)]

Proprietary Name: Acculmaging Common Name: Acculmaging Classification Name: Solid state x-ray imaging system Regulation Number: 21 CFR 892.1650 · Product Code: MQB Device Class: II

#### LEGALLY MARKETED PREDICATE DEVICE [21 CFR 807.92(a)(3)]

| Company | Trade Name | 510(k) Number |
|---------|--------------------------------------|---------------|
| Kodak | Eclipse Image<br>Processing Software | K060137 |

### DEVICE DESCRIPTION [21 CFR 807.92(a)(4)]

Acculmaging is a Dynamic Link Library (DLL) module that takes a raw X-rav image generated by a CR or DR as its input and produces a fidelity-quality image for diagnostic purposes. It interfaces with radiological software to analyze digital image data and optimize the processing parameters applied to enhance detail and thus images' diagnostic quality. Acculmaging is not a standalone module and does not implement any user interfaces; it provides a dedicated image processing function to a top-level application running in the Microsoft Windows operating system. It is bound into a parent application that provides user interfaces and dynamically loads the DLL module, forming an integrated process; and, it can also be linked to a service module to provide the image processing service to other top-level applications.

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## DEVICE INDICATION FOR USE [21 CFR 807.92(a)(5)]

Acculmaging is a software module capable of taking an X-ray image generated by a CR or DR and producing a digitally enhanced image for projection radiography applications. Acculmaging is not indicated for use in mammography.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [21 CFR 807.92(a)(6)]

The Acculmaging image processing software module is substantially equivalent to the predicate device in both the aspects of the algorithm characteristics and the performance quality, as shown in the table below.

| Characteristic | Proposed Device | Predicate Device |
|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Acculmaging is a software<br>module capable of taking an<br>X-ray image generated by a<br>CR or DR and producing a<br>digitally enhanced image for<br>projection radiography<br>applications. Acculmaging is<br>not indicated for use in<br>mammography. | The image processing<br>software, used with a cleared<br>CR or DR device, provides<br>diagnostic quality images to<br>aid physicians with diagnosis.<br>This excludes mammography<br>applications. |
| Materials | Software application | Software application |
| Where used | Radiology department and<br>medical imaging center | Radiology department and<br>medical imaging center |
| Technology | Software image processing<br>algorithms enhance the image<br>in both grayscale and K-<br>space. | Software image processing<br>algorithms enhance the image<br>in both grayscale and K-<br>space. |
| Performance | Performance data was<br>collected. The certification of<br>the equivalence of the<br>performance between the<br>proposed device and the<br>predicate device was<br>provided. | Performance data was<br>collected. The certification of<br>the equivalence of the<br>performance between the<br>proposed device and the<br>predicate device was<br>provided. |
| Image data source | CR reader or DR | CR reader or DR |
| Image data format | | |
| | The input and output image<br>pixel data is the raster data.<br>The photometric<br>representation of the image<br>pixel data is provided. | The input and output image<br>pixel data is the raster data.<br>The photometric<br>representation of the image<br>pixel data is provided. |
| | Operating systems | Microsoft Windows |
| | Noise reduction | The noise reduction is<br>realized with a weighted<br>average of local image pixel<br>values with a profile close to<br>Gaussian distribution. In<br>addition, the mediate value of<br>adjacent pixels is picked up to<br>replace the value of a single-<br>pixel random noise peak. |
| | Perceptual Tone<br>Scale (PTS),<br>mapping the linear<br>pixel value to<br>perceptual tone<br>scale. | The image pixel value<br>obtained from an image<br>acquisition instrument is<br>usually related to the input X-<br>ray intensity in a non-<br>logarithmic function, typically<br>a linear or square-root<br>function. This pixel value is<br>mapped to perceptual tone as<br>a logarithmic-like function of<br>the X-ray intensity at the<br>imager detector. The low-<br>intensity wing of the mapping<br>function is modified from the<br>logarithmic function for a<br>recovery from scattered light. |
| Edge Enhancement | The edge enhancement is<br>realized with a high-frequency<br>band-pass wavelet filter. | Although the detailed<br>algorithm is unknown, the<br>processed image implies that<br>the high-frequency<br>component is enhanced. |
| Enhanced<br>Visualization | The enhanced visualization<br>processing increases the | The detailed algorithm is<br>unknown. The processed<br>image indicates that a basic |
| Processing (EVP) | reducing its contrast, hence<br>reducing the need for the<br>radiologist to manipulate the<br>image. In the EVP, typically<br>the DC component of the<br>image is suppressed while the<br>gradient information of the<br>image is persisted. | DC component suppression<br>algorithm is applied. |
| Signal-dependent<br>algorithm to<br>optimize localized<br>features and noise<br>reduction | Adaptive algorithms deal with<br>noise reduction and intensity<br>energy leaks. | The noise reduction is<br>enhanced at the low-exposure<br>area. |
| Type of software<br>program | A dynamic link library module<br>as a part of the image<br>acquisition control program. | A component of the image<br>acquisition control program. |

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### COMPARISON OF DIFFERENCES

| Characteristic | Proposed Device | Predicate Device |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>Statements | Acculmaging is a software<br>module capable of taking an<br>X-ray image generated by a<br>CR or DR and producing a<br>digitally enhanced image for<br>projection radiography<br>applications. Acculmaging is<br>not indicated for use in<br>mammography. | The CR Systems are compact<br>laser scanners capable of<br>reading the latent image<br>formed on a storage phosphor<br>imaging plate and producing a<br>digital image for projection<br>radiography applications. This<br>excludes mammography<br>applications for the Kodak<br>Ektascan Storage Phosphor<br>Reader and the Kodak<br>Eclipse image Processing<br>Software in the United States. |

## DISCUSSION OF NONCLINICAL TESTS [21 CFR 807.92(b)(1)]

Eight image sets were presented to an expert. The expert was asked to read these images and then answer the following questions:

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- 1. In your professional opinion, do you feel that both sets of images are of diagnostic-quality?
- 2. In your professional opinion, do you feel that the images' features are equivalent in terms of detail?

The answers provided by the expert's comparative review support substantial equivalence and show that the new device does not introduce questions of safety or effectiveness when compared with the predicate device.

#### DISCUSSION OF CLINICAL TESTS [21 CFR 807.92(b)(1)]

No clinical testing data is being submitted for this Premarket Notification submission.

### CONCLUSION OF PERFORMANCE DATA ASSESSMENTS [21 CFR 807.92(b)(1)]

Based on the above comparisons and the comparative testing between the Acculmaging software module and the predicate device (Section 18) raises no new issues of safety and effectiveness.

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Image /page/5/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest movement and flight. The overall design is simple and recognizable, conveying a sense of authority and trustworthiness.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Radiology Information Systems, Inc. % Mr. E.J. Smith Regulatory Consultant Smith Associates 1468 Harwell Ave. CROFTON MD 21114

AUG 23 2013

Re: K102849

Trade/Device Name: Acculmaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 29, 2010 Received: September 29, 2010

Dear Mr. Smith:

This letter corrects our substantially equivalent letter of November 23, 2010.

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

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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 11 you desire spositiv an Artice of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Four may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely Yours,

Janine M. Morris

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

Enclosure

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## Indications for Use

NOV 2 3 2010

510(k) Number (if known): Kl 0 2 8 4 9

Device Name: Acculmaging

Indications for Use:

Acculmaging is a software module capable of taking an X-ray image generated by a CR or DR and producing a digitally enhanced image for projection radiography applications. Acculmaging is not indicated for use in mammography.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Boxico Evaluation (120E).

(Division Sign-Off)

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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
KOSKO

510K K162849

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