K Number

Device Name

ONDEMAND3D

Manufacturer

CYBERMED, INC.

Date Cleared

2011-12-16

(15 days)

Product Code

LLZ

Regulation Number

892.2050

Intended Use

The OnDemand3D92 is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. It also provides the following functions as shown below. - 1) Functions for implant surgery planning and fabricating a surgical guide according to the plan - 2) Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time - 3) Functions to create orthodontic analysis using 3D volume data - 4) Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name

Device Description

OnDemand3DS2 is a personal computer based dental imaging software which I oads DICOM images taken from CT, MR and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis. It is also intended to plan an implant surgery, fabricate a surgical guide according to the plan, superimpose and stitch multi DICOM da ta sets, mark anatomical landmark from CT data and provide analyzed data for orthodontic treatment while software provides 2D image viewing module enabli ng 2D image acquisition specialized in 2D scanned image supporting DICOM, BITMAP, JPG, TIF. OnDemand3D22 is designed to provide with users and familiar user-interface easy. Also OnDemand3D22 makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions.

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

K070464, K033849, K070803, K061370

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard medical imaging software functionalities like 3D visualization, 2D analysis, MPR, and image manipulation for planning and analysis, without mentioning any AI or ML techniques.

Therapeutic

No.
The device is a software package for medical image visualization and analysis, diagnosis, and planning, not for direct therapeutic intervention.

Diagnostic

Yes
The device is intended for "rapid and precise diagnosis" and provides "various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis." Its stated purpose to aid in diagnosis makes it a diagnostic device.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is "a personal computer based dental imaging software" and details its functions related to processing and analyzing medical images. There is no mention of accompanying hardware components being part of the device itself.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The OnDemand3D92 software processes and analyzes medical images (CT, MR, X-Ray, PET, etc.) that are acquired from the patient's body. It does not interact with or analyze specimens taken from the body.
Intended Use: The intended use focuses on image visualization, analysis, surgical planning, and orthodontic analysis based on imaging data. These are all activities performed on the imaging data, not on biological specimens.

Therefore, the OnDemand3D92 software falls under the category of medical imaging software or picture archiving and communication systems (PACS) with advanced visualization and analysis capabilities, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

It also provides the following functions as shown below.

1. Functions for implant surgery planning and fabricating a surgical guide according to the plan
1. Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time
1. Functions to create orthodontic analysis using 3D volume data
1. Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name

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

LLZ

Device Description

OnDemand3D22 is designed to provide with users and familiar user-interface easy. Also OnDemand3D22 makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions. The main functions of OnDemand3D62 are as follows.

1. Main Function
(1) DBM(Data base Manager)

The operator can use DICOM images stored in Master database, Local databases or Remote PACS servers more conveniently with user-familiar interface such as Window explorer. DBM supports CD-R/RW to keep necessary DICOM images in CD directly. DBM supports to make multiple Local databases so it is very convenient for multiple users on one system.

(2) LightBox
LightBox supports to load different types of DICOM images such as 8/12/16 bits gray images and color images. LightBox provides 'CINE Player' to display multiframe DICOM images. LightBox supports a preview image on Window print and DICOM print screen.

(3) Dental Reformat

Dental Reformat makes it possible to reconstruct Panoramic and Cross sectional images. Conventional imaging solutions are supported, and also new imaging solutions such as Volume Rendering, 3D Scout are supported. The layout and images are optimized for Reporting.

(4) 3D
3D makes it possible to switch rendering mode such as VR(Volume Rendering), MIP/MinIP more easily and conveniently. 3D provides more accurate images by using various rendering functions such as MPR Rotating, Curve, 3D Zoom, Clip.

(5) X-ray Generation

X-ray Generation makes it possible to create X-ray images for cephalometric analysis. Lateral X-ray image and frontal X-ray image can be generated in X-ray Generation module.

(6) Report

Report makes it possible to make a report more easily by using intuitive user interface and also export it to HTML format document. The operator can capture necessary images on all screens of OnDemand3D62 with Pane-Capture/Region-Capture function and insert the captured images to Report very easily.

(7) In2quide

In2Guide is designed for the purpose of easy implant planning and short operating time with high accuracy. In2Guide provides functionality for diagnosis, implant planning and implant, abutment library of many manufacturers.

(8) Fusion

Fusion is a visualization tool using a registration technique to combine and show the image data from different modalities such as CT,MRI and PET in one window at the same time. A Fusion window consists of each MPR image of the Primary, Secondary and Fused pane matched between two images. In the case of images comes from same patients we can compare the changes between pre and postoperation. Fusion provides functions for loading two series of Primary and Secondary images and saving the fused image as a new DICOM series.

(9) 3D Ceph

3D Ceph provides precise analysis result using formulas based on anatomical landmarks of patient. Landmarks and formulas can be customizable. The key features of 3D Ceph are comparing pre-operation with post-operation by superimposition, photo mapping and 2D X-ray image generation,

(10) X-Image

X-Image module is management solution for both 2D and 3D images. X-Image sorts images by patient name and it handles images from Panorama, Cephal ometric, Intraoral, Conebeam CT. The operator can also view 2D images with built in filter and image tools.

3) Information of the image format

OnDemand3D92 can load only DCM files and save results as DCM, BMP and JPG files.

DCM : DICOM (Digital Image Communication in Medicine) is a Standard Protocol to exchange and transfer the data acquired by Medical Image devices such as a CT, MR, 3D US, etc. It is designated as a Standard Protocol by ACR-NEMA (American College of Radiology-National Electrical Manufacturers Association) and now adopted by most Medical Imaging Devices. OnDemand3D02 2.0 is adaptable technically for all data of DICOM 3.0.
Reference : Digital Imaging and Communications in Medicine (DICOM) ACR-NEMA Standards Publication PS 3.1~PS 3.16 2003.
BMP : The standard bit-mapped graphics format used in the Windows environment. By convention, graphics files in the BMP format end with a BMP extension. BMP files store graphics in a format called device-independent bitmap (DIB).
JPG/JPEG : Short for "Joint Photographic Experts Group", the original name of the committee that wrote the standard. JPG is one of the image file formats supported on the Web. JPG images support 16 million colors and are best suited for photographs and complex graphics.
1. Compression
Compression Method : Lossless Compression

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR, X-Ray, PET, 3D US, Panorama, Cephalometric, intraoral

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

Not Found

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.

K070464, K033849, K070803, K061370

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

K113543

510(k) Summary

DEC 1 6 2011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

And Production Comments of Research

Date: _May. 30, 2011

Company and Correspondent making the submission:

· Name - CyberMed, Inc. Address - #504 SJ Technoville, Gasan-dong 60-19, Geumcheon-gu, Seoul, 153-710, Korea Telephone - +82-2-3397-3970 Fax - +82-2-3397-3971 Contact – Mr. Yong Ki Im / RA Manager

1. Device :

Trade/proprietary name	: OnDemand3DG2
Common Name	: Picture archiving and communications system
Classification Name	: System, image processing, radiological

3. Predicate Devices :

Manufacturer:	: CyberMed, Inc.
Device:	: OnDemand3D™
510(k) Number:	: K070464 (Decision Date - 03/16/2007)
Manufacturer:	: Materialise, N.V.
Device:	: SimPlant System
510(k) Number:	: K033849 (Decision Date - 05/25/2004)
Manufacturer:	: Anatomage, Inc.
Device:	: Invivo Dental
510(k) Number:	: K070803 (Decision Date - 04/06/2007)
Manufacturer:	: GE Medical systems SCS

Device:	: CardIQ Fusion
510(k) Number:	: K061370 (Decision Date - 05/30/2006)

1. Classifications Names & Citations :
  21CFR 892.2050, LLZ, Picture archiving and communications system, Class2
1. Description :
- 1. General Description

1. Main Function
(1) DBM(Data base Manager)

(2) LightBox
LightBox supports to load different types of DICOM images such as 8/12/16 bits gray images and color images. LightBox provides 'CINE Player' to display multiframe DICOM images. LightBox supports a preview image on Window print and

DICOM print screen.

(3) Dental Reformat

(4) 3D

3D makes it possible to switch rendering mode such as VR(Volume Rendering), MIP/MinIP more easily and conveniently. 3D provides more accurate images by using various rendering functions such as MPR Rotating, Curve, 3D Zoom, Clip.

(5) X-ray Generation

X-ray Generation makes it possible to create X-ray images for cephalometric analysis. Lateral X-ray image and frontal X-ray image can be generated in X-ray Generation module.

(6) Report

(7) In2quide

(8) Fusion

Secondary and Fused pane matched between two images. In the case of images

CyberMed. Inc.

comes from same patients we can compare the changes between pre and postoperation. Fusion provides functions for loading two series of Primary and Secondary images and saving the fused image as a new DICOM series.

のお気になるときです。私は私は気になるところした。このため、ということで、このとコー

(9) 3D Ceph

(10) X-Image

3) Information of the image format

OnDemand3D92 can load only DCM files and save results as DCM, BMP and JPG files.

DCM : DICOM (Digital Image Communication in Medicine) is a Standard Protocol to exchange and transfer the data acquired by Medical Image devices such as a CT, MR, 3D US, etc. It is designated as a Standard Protocol by ACR-NEMA (American College of Radiology-National Electrical Manufacturers Association) and now adopted by most Medical Imaging Devices. OnDemand3D02 2.0 is adaptable technically for all data of DICOM 3.0.
Reference : Digital Imaging and Communications in Medicine (DICOM) ACR-NEMA Standards Publication PS 3.1~PS 3.16 2003.
BMP : The standard bit-mapped graphics format used in the Windows environment. By convention, graphics files in the BMP format end with a BMP extension. BMP files store graphics in a format called device-independent bitmap (DIB).
JPG/JPEG : Short for "Joint Photographic Experts Group", the original name of the committee that wrote the standard. JPG is one of the image file formats supported

on the Web. JPG images support 16 million colors and are best suited for photographs and complex graphics.

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

1. Compression
Compression Method : Lossless Compression
1. Indication for use :
  The OnDemand3DG2 is intended for use as a software package which loads DICOM images from CT, MR, X-Ray, stores those and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
It also provides the following functions as shown below.
1. Functions for implant surgery planning and fabricating a surgical guide according to the plan
1. Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time
1. Functions to create orthodontic analysis using 3D volume data
1. Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name
1. Comparison with predicate device :

CyberMed, Inc., ensures that the OnDemand3D92, Picture archiving and communications system is substantially equivalent to OnDemand3D™ of CyberMed, Inc., SimPlant System of Materialise N.V., Invivo Dental of Anatomage Inc., CardIQ Fusion of GE Medical systems SCS.

The similarities are as follows.

SALES THE COLLECT THE COLLECT

User, Computer Platform, Communication, PACS Server, DICOM data transferring, Archiving data Format, Image format In, Image Compression, Image Archive, Image Display, Image Reformation, 3D Image Construction, Image Projection, Image Edit, Basic Image Operation, Measurements, Other Function, Report, Printing

And the additional similarities are as follows.

Similarity between OnDemand3D92 In2Guide module and SimPlant System

1. Similarity between OnDemand3D02 Fusion module and CardIQ Fusion
  のお気になるところです。ここではないとなっているというとなると、その
1. Similarity between OnDemand3D62 3D Ceph module and Invivo Dental
  And the Differences are as follows.
1. Differences between OnDemand3D 92 In2Guide module nd SimPlant System
1. Differences between OnDemand3DS2 3D Ceph module and Invivo Dental (3D Analysis)

There are a little bit of differences between the OnDemand3D62 and Predicate Devices (OnDemand3D™, SimPlant System_Invivo Dental, CardIQ Fusion) as above. But eventually, these differences do not cause any problems in the safety and effectiveness.

Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification CyberMed, Inc. concludes that OnDemand3D2 is safe and effective and substantially equivalent to predicate devices as described herein.

1. CyberMed, Inc. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

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

CyberMed Inc. % Mr. Marc M. Mouser Engineering Leader & FDA Office Coordinator, Program Reviewer Underwriters Laboratories Inc. 2600 NW Lake Road CAMAS WA 98607

DEC 1 6 2011

Re: K113543

Trade/Device Name: Picture Archiving Communications System/OnDemand3D902 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 1, 2011 Received: December 1, 2011

Dear Mr. Mouser:

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 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,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Page 2

Indications for Use

510(k) Number(if known): K | 3543

Device Name: Picture Archiving Communications System / OnDemand3D62

Indications for Use:

It also provides the following functions as shown below.

1. Functions for implant surgery planning and fabricating a surgical guide according to the plan
1. Functions to combine and show the image data from different modalities such as CT, MRI and PET in one window at the same time
1. Functions to create orthodontic analysis using 3D volume data
1. Functions to sort and save DICOM files, Project Files and 2D image files from different modality [Panorama, Cephalometric, intraoral] under a single patient name

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (Part 21 CFR 807 Subpart C)

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

Mary S Patel

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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