(41 days)
Not Found
No
The document describes a standard PACS system with image storage, communication, processing, and display capabilities, including an orthopedic planning module. There is no mention of AI, ML, deep learning, or any related concepts in the provided text. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".
No
This device is a PACS system used for storing, communicating, processing, and displaying medical images, including an application for orthopedic preoperative planning. It does not directly treat or diagnose diseases or conditions.
No
The device is described as an image management system that stores, communicates, processes, and displays medical images. While it aids in preoperative planning and post-operative follow-up by orthopedic surgeons, it does not analyze or interpret medical data to diagnose a condition, but rather displays the images for human interpretation.
No
The device description explicitly mentions acquiring images using a DICOM gateway and film digitizers, which are hardware components. While the core functionality is software-based image management and processing, the system includes or interacts with hardware for image acquisition.
Based on the provided information, the UltraPACS™ system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description of UltraPACS™ clearly state that it receives, stores, processes, and displays digital images and data from various imaging modalities (CT, MR, ultrasound, etc.). It does not involve the analysis of biological samples like blood, urine, or tissue.
- The primary function is image management and display. While it includes features for orthopedic planning and image processing, its core purpose is handling medical images, not performing diagnostic tests on biological specimens.
The device falls under the category of a Picture Archiving and Communication System (PACS) with additional features for image processing and orthopedic planning. These types of devices are regulated as medical devices, but not as IVDs.
N/A
Intended Use / Indications for Use
UltraPACS™ system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
Product codes
LLZ
Device Description
UltraPACS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to UltraPACS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation. The orthopedic application is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The orthopedic application of the device is used to overlay prosthesis templates on radiological images, tools for repositioning the templates. and tools for measurements in the images.
UltraPACS™ is a Picture Archiving and Communications device that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, physicians, nurses, and technicians.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 1 5 2005
Image /page/0/Picture/2 description: The image shows a logo with the word "ultra" stacked on top of the word "RAD". The word "ultra" is in a smaller, italicized font, while "RAD" is in a larger, bold font. The logo is black and white and has a simple, clean design.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: June 27, 2005
Submitter's Information: 21 CFR 807.92(a)(1) Tom Goliash, President / CEO UltraRAD Corporation 801 West Bay Drive, Suite 424 Largo, FL 33770 Tel: 800-719-9379 Email: tgoliash@ultraradcorp.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade name - UltraPACS™ by UltraRAD Corporation Common name - Picture, Archive, and Communications System Classification name - system, image processing, radiological (21 CFR 880.2050, Product Code LLZ)
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | System, Image Processing,
Radiological | System, Image Processing,
Radiological |
|----------------------------|-------------------------------------------|-------------------------------------------|
| Regulation Number | 892.2050 | 892.2050 |
| 510(k) Number | K042311 | K041500 |
| Device Name | PACSPartner | StarPACS Ortho |
| Applicant | Medical Standard Co. Ltd. | Infinitt Co. Ltd. |
| Product Code | LLZ | LLZ |
| Decision Date | 09/09/2004 | 06/21/04 |
Device Description: 21 CFR 807 92(a)(4)
UltraPACS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to UltraPACS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation. The orthopedic application is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The orthopedic application of the device is used to overlay prosthesis templates on radiological images, tools for repositioning the templates. and tools for measurements in the images.
Indications for Use: 21 CFR 807 92(a)(5)
UltraPACS™ system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other
1
Image /page/1/Picture/0 description: The image shows a logo with the word "ultra" stacked on top of the word "RAD". The word "ultra" is in a cursive font and is smaller than the word "RAD". The word "RAD" is in a bold, sans-serif font. The logo is black and white.
imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
UltraPACS™ is a Picture Archiving and Communications device that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for UltraPACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
UltraPACS™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Minor".
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a bold, sans-serif font. The text is black and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UltraRAD Corporation % Mr. Carl Alletto Official Correspondent 1600 Manchester Way CORINTH TX 76210
Re: K051813
Trade/Device Name: UltraPACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: June 27, 2005 Received: July 13, 2005
Dear Mr. Alletto:
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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
AUG 1 5 2005
3
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
4
(Indications for Use Form)
510(k) Number: K051813
Device Name: UltraPACS™
Indications for Use:
UltraPACS™ system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
David B. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K051813