K Number

Device Name

ACCULMAING

Manufacturer

RADIOLOGY INFORMATION SYSTEMS, INC.

Date Cleared

2010-11-23

(55 days)

Product Code

LLZ MQB

Regulation Number

892.2050

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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K060137

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional image processing techniques and does not mention AI, ML, or related concepts. The performance study is a simple comparative review by an expert, not indicative of AI/ML model validation.

Therapeutic

No
The device enhances X-ray images for diagnostic purposes, not for treating diseases or conditions.

Diagnostic

Yes
The device description states that AccuImaging "produces a fidelity-quality image for diagnostic purposes." Additionally, the performance studies involve an expert assessing if images are "of diagnostic-quality."

SaMD (Software as a Medical Device)

Yes

The device is described as a software module (DLL) that takes a digital image as input and produces a digitally enhanced image. It explicitly states it is not a standalone module and interfaces with other software, indicating it is purely a software component without associated hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, Acculmaging is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Acculmaging's Function: Acculmaging processes X-ray images, which are generated externally to the body and are not biological samples. Its purpose is to enhance the visual quality of these images for diagnostic interpretation by a radiologist.
No Biological Sample Analysis: The description clearly states that Acculmaging takes a "raw X-ray image" as input and produces a "digitally enhanced image." There is no mention of analyzing any biological material.

Therefore, Acculmaging falls under the category of medical image processing software rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

MQB, LLZ

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray image generated by a CR or DR

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Radiology department and medical imaging center

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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

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

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Comparative review
Sample Size: 8 image sets
Key Results: 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060137

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(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).

Summary

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: 888-729-9674

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
Processing Software	K060137

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

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

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
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.	The image processing
software, used with a cleared
CR or DR device, provides
diagnostic quality images to
aid physicians with diagnosis.
This excludes mammography
applications.
Materials	Software application	Software application
Where used	Radiology department and
medical imaging center	Radiology department and
medical imaging center
Technology	Software image processing
algorithms enhance the image
in both grayscale and K-
space.	Software image processing
algorithms enhance the image
in both grayscale and K-
space.
Performance	Performance data was
collected. The certification of
the equivalence of the
performance between the
proposed device and the
predicate device was
provided.	Performance data was
collected. The certification of
the equivalence of the
performance between the
proposed device and the
predicate device was
provided.
Image data source	CR reader or DR	CR reader or DR
Image data format
	The input and output image
pixel data is the raster data.
The photometric
representation of the image
pixel data is provided.	The input and output image
pixel data is the raster data.
The photometric
representation of the image
pixel data is provided.
	Operating systems	Microsoft Windows
	Noise reduction	The noise reduction is
realized with a weighted
average of local image pixel
values with a profile close to
Gaussian distribution. In
addition, the mediate value of
adjacent pixels is picked up to
replace the value of a single-
pixel random noise peak.
	Perceptual Tone
Scale (PTS),
mapping the linear
pixel value to
perceptual tone
scale.	The image pixel value
obtained from an image
acquisition instrument is
usually related to the input X-
ray intensity in a non-
logarithmic function, typically
a linear or square-root
function. This pixel value is
mapped to perceptual tone as
a logarithmic-like function of
the X-ray intensity at the
imager detector. The low-
intensity wing of the mapping
function is modified from the
logarithmic function for a
recovery from scattered light.
Edge Enhancement	The edge enhancement is
realized with a high-frequency
band-pass wavelet filter.	Although the detailed
algorithm is unknown, the
processed image implies that
the high-frequency
component is enhanced.
Enhanced
Visualization	The enhanced visualization
processing increases the	The detailed algorithm is
unknown. The processed
image indicates that a basic
Processing (EVP)	reducing its contrast, hence
reducing the need for the
radiologist to manipulate the
image. In the EVP, typically
the DC component of the
image is suppressed while the
gradient information of the
image is persisted.	DC component suppression
algorithm is applied.
Signal-dependent
algorithm to
optimize localized
features and noise
reduction	Adaptive algorithms deal with
noise reduction and intensity
energy leaks.	The noise reduction is
enhanced at the low-exposure
area.
Type of software
program	A dynamic link library module
as a part of the image
acquisition control program.	A component of the image
acquisition control program.

COMPARISON OF DIFFERENCES

Characteristic	Proposed Device	Predicate Device
Indications for Use
Statements	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.	The CR Systems are compact
laser scanners capable of
reading the latent image
formed on a storage phosphor
imaging plate and producing a
digital image for projection
radiography applications. This
excludes mammography
applications for the Kodak
Ektascan Storage Phosphor
Reader and the Kodak
Eclipse image Processing
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:

1. In your professional opinion, do you feel that both sets of images are of diagnostic-quality?
1. 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.

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

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 (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 Four may 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/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

Indications for Use

NOV 2 3 2010

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

Device Name: Acculmaging

Indications for Use:

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)

Page 1 of

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

510K K162849