(28 days)
Not Found
No
The summary describes standard medical imaging software functionalities like 3D visualization, 2D analysis, and MPR, without mentioning any AI/ML specific terms or capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a software package for image visualization and analysis for diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides functions "for further rapid and precise diagnosis."
Yes
The device description explicitly states it is a "personal computer based dental imaging software" and details its functions as loading, storing, visualizing, and analyzing DICOM images, all of which are software-based operations. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for loading, storing, visualizing, and analyzing medical images (CT, MR, X-Ray) for the purpose of diagnosis. This is a function performed on the patient's anatomical data, not on a sample taken from the patient (like blood, urine, or tissue).
- Device Description: The description reinforces that it's a software for processing and analyzing medical images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This software operates on medical images, which are a representation of the patient's anatomy, not a biological sample.
N/A
Intended Use / Indications for Use
The OnDemand3D™ 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
OnDemand3D™ is a personal computer based dental imaging software which loads 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. OnDemand3D™ is designed to provide users easy and familiar user-interface. Also OnDemand3D™ makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with various rendering functions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM images from CT, MR, X-Ray
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.
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
§ 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).
0
070464
11
MAR 1 6 2007
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
のお気になると、その他のお気になるということです。 この
Date: _Dec. 27, 2006
-
- 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. Song Nak Choi/ Manager
- Company and Correspondent making the submission:
-
- Device :
| Trade/proprietary name | : OnDemand3D™ |
|---|---|
| Common Name | : Picture archiving and communications system |
| Classification Name | : Picture archiving and communications system |
-
- Predicate Devices :
| Manufacturer: | : TIS Inc. |
|---|---|
| Device: | : APAXTM |
| 510(k) Number: | : K032760 (Decision Date - 09/17/2003) |
| Manufacturer: | : MATERIALISE N.V. |
| Device: | : SimPlant System |
| 510(k) Number: | : K033849 (Decision Date - 05/25/2004) |
| Manufacturer: | : MEVISYS, Co., Ltd. |
| Device: | : VOXELPLUSTM PACS |
| 510(k) Number: | : K022692 (Decision Date - 10/11/2002) |
#504 SJ Technoville, Gasan-dong 60-19, Geumcheon-gu, Seoul, 153
1
-
- Classifications Names & Citations :
21CFR 820.2050, LLZ, Picture archiving and communications system, Class2
- Classifications Names & Citations :
-
- Description :
-
- General Description
OnDemand3D™ is a personal computer based dental imaging software which loads 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.
OnDemand3D™ is designed to provide users easy and familiar user-interface. Also OnDemand3D™ 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 OnDemand3D™ are as follows.
-
- Main Function
- (1) DBM(Data base Manager)
You 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 and so on are supported. The layout and images are optimized for Reporting.
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CyberMed. Inc.
- (4) 3D
3D makes it possible to switch rendering mode such as VR(Volume Rendering), MIP/MinIP, and etc. more easily and conveniently. 3D provides more accurate images by using various rendering functions such as MPR Rotating, Curve, 3D Zoom, Clip, etc.
のお気になるので、その他のお気になるのですが、このままのお気にしています
-
(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. You can capture necessary images on all screens of OnDemand3D™ with Pane-Capture/Region-Capture function and insert the captured images to Report very easily.
3) Information of the image format
OnDemand3D™ 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. OnDemand3D™ 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
3
CyberMed, Inc.
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.
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4) Compression
- Compression Method : Lossless Compression
6. Indication for use :
The OnDemand3D™ 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.
7. Comparison with predicate device :
CyberMed, Inc., believes that the OnDemand3D™, Picture archiving and communications system is substantially equivalent to APAX™ of TIS, Inc., SimPlant System of MATERIALISE N.V. and VOXELPLUS™ PACS of MEVISYS, Co., Ltd..
8. 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 OnDemand3D™ is safe and effective and substantially equivalent to predicate devices as described herein.
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- CyberMed, Inc. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
CyberMed, Inc. c/o Mr. Marc M. Mouser Senior Project Engineer/Program Reviewer 2600 NW Lake Road CAMAS WA 98607
Re: K070464
Trade/Device Name: OnDemand3DTM Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 31, 2007 Received: February 16, 2007
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/4/Picture/10 description: The image is a circular logo with the text "1906-2006 FDA Centennial" in the center. The letters "FDA" are large and bolded. There are three stars below the word "Centennial". The text "Food and Drug Administration" is written around the perimeter of the circle.
Protesting and Promoting Public Health
5
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.
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 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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070464
Indications for Use
510(k) Number(if known):
Device Name: OnDemand3D™
Indications for Use:
The OnDemand3D™ 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Daniel h. bogman
(Division Sign-Off)
Page 1 of _1
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number