CS Orthodontic Imaging and CS OMS Imaging software is intended for use by orthodontists, oral surgeons, and their clinical staffs in storing and organizing images. including digital photographs, x-rays, and others. The system includes the capability to trace a cephalometric x-ray, analyze the measurements taken, and make growth or surgical predictions.

Device Description

CS Orthodontic Imaging and CS OMS Imaging software is a modification of currently legally marketed Kodak Orthodontic and OMS Imaging v8.0 software (K043104). The software is intended for installation at orthodontic or oral surgery clinics and offices on general purpose off-the-shelf computers systems (PCs) running Microsoft Windows in a peer-to-peer network.

Both the modified and unmodified devices consist of imaging software for orthodontic and oral surgery practices. The software provides the ability to connect satellite offices and may be marketed as a base system, with additional modules offered as options. The base system includes the storage, annotation and display of images. The optional Analysis module enables the user to trace the cephalometric x-rays using standard analyses. The optional Planner module enables the user to simulate orthodontic or surgical treatment in order to communicate treatment objectives or demonstrate and explain potential surgery to the patient.

When used with Carestream's panoramic, cephalometric, and other imaging systems, the device provides an interface that enables the practitioner to acquire radiographic images of the dentomaxillofacial region. The software then allows the user to visualize anatomical structures through the use of a computer display and store the information electronically in a clinical software program. CS Orthodontic and OMS Imaging software includes records of hard and softcopy charts, treatment plans, clinical notes, and clinical exam data. The software also enables the user to retrieve an electronic copy of an x-ray image from other imaging systems.

The device includes options for image viewing or presentation, including thumbnail viewing, single image viewing, and merging images into a letter (i.e., as part of a written communication to the patient). The image manipulation options include grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, d-speckle, hue, saturation, equalize, flip, mirror, masking, and rotate functions. Image annotation functions allow the user to add text to images, to measure distances and angles, magnify images, and other functions.

CS Orthodontic and OMS Imaging software can be integrated with Carestream's dental and dental sub-specialty practice management system software or used as a stand-alone product.

AI/ML Overview

The provided text does not contain detailed acceptance criteria, a specific study, device performance data, sample sizes for test or training sets, information on ground truth establishment, expert qualifications, or adjudication methods for the "CS Orthodontic Imaging and CS OMS Imaging software".

This 510(k) summary is for a device that is a modification of a previously legally marketed device (Kodak Orthodontic and OMS Imaging v8.0, K043104). The submission relies on establishing substantial equivalence to this predicate device rather than presenting a standalone clinical trial with detailed performance metrics against specific acceptance criteria.

Missing Information from the Provided Text:

No specific acceptance criteria are mentioned for device performance.
No details about a specific study proving the device meets acceptance criteria are provided. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing.
No table of acceptance criteria and reported device performance.
No sample sizes (test or training set) or data provenance.
No information on the number or qualifications of experts used for ground truth.
No adjudication method.
No mention of a multi-reader multi-case (MRMC) comparative effectiveness study.
No standalone algorithm performance study details.
Type of ground truth used is not specified.
No sample size for the training set.
No details on how ground truth for the training set was established.

Key statements from the document regarding testing:

"Verification and validation testing of the CS Orthodontic Imaging and CS OMS Imaging software has been performed, including verification of all specified software and hardware interfaces. Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use." (Section 8. Non-Clinical testing)

This statement indicates that verification and validation were performed, but it does not provide the specific metrics, criteria, or study results that would allow for a detailed analysis as requested. The primary method for demonstrating safety and effectiveness in this 510(k) appears to be through the comparison table showing features and functionalities are "Same" or enhanced compared to the predicate device, implying that the established safety and effectiveness of the predicate device extend to this modified, substantially equivalent device.

Summary

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K122427
Page 1 of 4

CS Orthodontic Imaging and CS OMS Imaging software

Carestream Dental, LLC

SEP 12 2012

510(k) Summary CS Orthodontic Imaging and CS OMS Imaging software

1. Company Identification

Carestream Dental LLC 1765 The Exchange Atlanta, GA 30339 Establishment Registration 1226003 Owner/Operator: Carestream Health, Inc. Owner/Operator Registration: 9097221

2. Contact Person

Daniel Hoefer Manager, Regulatory Affairs, Carestream Dental 1765 The Exchange Atlanta, GA 30339 Tel 770 226 3287 Fax 770 850 5011

3. Device Name

Commercial name: CS Orthodontic Imaging, CS OMS Imaging Common name: Dental Imaging Software Classification name: System, Image Processing, Radiological

4. Device Classification

Class: II, 21 CFR 892.2050 Product Code: LLZ

5. Intended Use

6. Device Description

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K122427
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CS Orthodontic Imaging and CS OMS Imaging software

Carestream Dental, LLC

CS Orthodontic and OMS Imaging software can be integrated with Carestream's dental and dental sub-specialty practice management system software or used as a stand-alone product.

7. Substantial Equivalence

CS Orthodontic Imaging software and CS OMS Imaging software is substantially equivalent to Kodak Orthodontic and OMS Imaging 8.0 (K043104). See comparison table below (pages 3-4).

8. Non-Clinical testing

Verification and validation testing of the CS Orthodontic Imaging and CS OMS Imaging software has been performed, including verification of all specified software and hardware interfaces. Results of testing demonstrate that the device is safe and effective in meeting user requirements in accordance with its intended use.

9. Conclusion

CS Orthodontic Imaging and CS OMS Imaging software is substantially equivalent to Kodak Orthodontic and OMS Imaging 8.0, the predicate device listed above.

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K122427
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CS Orthodontic Imaging and CS OMS Imaging software

Characteristic

Carestream Dental, LLC

Comparison Table
Kodak Orthodontic and OMS Imaging 8.0	CS Orthodontic and OMS Imaging v11.0
K043104	pending
PracticeWorks Systems. LLC	Carestream Dental LLC (formerly

Characteristic	Kodak Orthodontic and OMS Imaging 8.0	CS Orthodontic and OMS Imaging v11.0
510(k) number	K043104	pending
Manufacturer	PracticeWorks Systems, LLC	Carestream Dental LLC ( formerlyPracticeWorks Systems, LLC)
Branding	Kodak	CS
Indications foruse	Indicated for Use by Orthodontists andclinical staff for storing and organizing digitalimages, including digital photographs and xrays. The device includes the capability totrace digital cephalometric radiographs,analyze measurements taken, and makegrowth projections	Indicated for Use by Orthodontists and clinicalstaff for storing and organizing digital images,including digital photographs and x rays. Thedevice includes the capability to trace digitalcephalometric radiographs, analyzemeasurements taken, and make growthprojections
Platform	IBM-compatible PC or PC network	Same
OperatingSystem	Microsoft Windows	Same
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image InputSources	Images can be scanned, loaded fromscanners, digital cameras or card readers, orimported from a radiographic imaging device.	Images can be scanned, loaded from digitalcameras or card readers, or imported from aradiographic imaging device.
32-bit software	Yes	Yes
Image formats	Multiple, including DICOM	Multiple, including DICOM
PatientDatabaseCompatibility	Access	SQL
User Functions
Characteristic	Kodak Orthodontic and OMS Imaging 8.0	CS Orthodontic and OMS Imaging v11.0
Includes Imagemeasurementtools	Yes (linear distance, angle)	Yes (linear distance, angle)
Interface withCarestreamimaging devices	Image acquisition from:Kodak 8000 panoramic imagingsystem, Kodak 8000C pan/ceph, RVG 6000 intraoral sensor, Kodak 1000 Intraoral camera	Image acquisition from:Kodak 8000 panoramic imagingsystem, Kodak 8000C pan/ceph, Kodak 9000/9000C/9000 3D Kodak 9500 3d Imaging system,CS 9300/9300C 3d imaging system RVG 6000, RVG 5000, RVG 6100,RVG 5100, and RVG 6500 intraoralsensors Kodak 1000, Kodak 1500
		radiography systems
Image viewing	Full, side-by-side, gallery, thumbnail	Full, side-by-side, gallery, thumbnail, filmstrip
Imagemanipulation	grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize, flip,mirror, masking, rotate, annotation,cephalometric tracing, ceph growthprojections, implant simulations	Same
CephalometricTracing	In addition to user-configured analysis,standard orthodontic tracing analysesinclude:Downs Jarabek McNamara Ricketts Roth Sassouni Steiner Tweed	Same
Growthprojections	Simulated Growth projections on lateralphotos used for patient communication	Same
Implant module	Simulates Generic implants only	Include implant libraries from Nobel Biocare,Bicon, 3i, and Straumann, and generic.
3D imagingcapabilities	None	None.Includes interface to 3D imaging softwareprovided with Kodak 9000, Kodak 9500, or CS9300 systems.CS Orthodontic and OMS Imaging softwaredoes not view, transfer or process 3Dradiographs.
ImageAnnotation	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,redeye reduction, select region, copy/paste

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化 122477 Page 4 of 4

CS Orthodontic Imaging and CS OMS İmaging software

Carestream Dental, LLC

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Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single snake entwined around a staff.

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

SEP 12 2012

Mr. Daniel Hoefer Manager, Regulatory Affairs Carestream Dental LLC 1765 The Exchange ATLANTA GA 30339

Re: K122427

Trade/Device Name: CS Orthodontic Imaging and CS OMS Imaging software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 7, 2012 Received: August 10, 2012

Dear Mr. Hoefer:

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 requirements as bet form in are qu your device as described in your Section 510(k) premarket with anow you to begal mading of substantial equivalence of your device to a legally marketed nonicate 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 done openite 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 5 150. Thous productions of the regarding the reporting 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 I ou 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/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

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

CS Orthodontic Imaging and CS OMS Imaging software is indicated for use by orthodontists or oral maxillofacial surgeons and their clinical staff in storing and organizing images, including digital photographs and x-rays. The device includes the capability to trace a digital cephalometric radiograph, analyze the measurements taken and make growth or surgical predictions.

Concurrence of CDRH, Office of Device Evaluation

X Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter

Arhuf D. O'th
(Division Sign-Off)
Division of Radiological Devices

Division of Radiological Devices
S10k 61224987

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).