(174 days)
Not Found
No
The document describes a standard PACS system with image processing features like MPR, AT, and 3D display, but there is no mention of AI, ML, or related concepts. The lack of information on training/test sets and performance metrics further supports this conclusion.
No
The device is a Picture Archiving and Communication System (PACS) intended for viewing, storing, and managing medical images, which are diagnostic functions, not therapeutic.
No
Explanation: The device processes, displays, stores, and archives medical images but does not actively interpret them or provide a diagnosis. It is a Picture Archiving and Communication System (PACS) that facilitates image review by medical professionals, who then make the diagnosis.
Yes
The device description and intended use clearly define a Picture Archiving and Communication System (PACS). PACS are inherently software-based systems designed to manage, store, retrieve, and display medical images. While they interact with hardware (imaging modalities, workstations, storage), the core device being described is the software itself. There is no mention of accompanying hardware being part of the device submission.
Based on the provided information, this device 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.
- Device function: The description clearly states that Rational Imaging PACS is used for the acquisition, display, processing, review, storage, and transmission of medical images from various imaging modalities (CT, MRI, etc.). These are images of the body itself, not tests performed on samples taken from the body.
- Intended Use: The intended use is for physicians and medical professionals to manage and review medical images for diagnostic purposes, which is distinct from performing in vitro tests.
Therefore, Rational Imaging PACS falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Rational Imaging PACS is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.
Product codes
LLZ
Device Description
Rational Imaging PACS is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices such as film digitizers or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiological Laboratory or Doctors office
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 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
OCT 3 0 2003
510(k) Summary of Safety and Effectiveness
K 031473
Submitted by
Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061
818-347-8919 (phn) 818-347-8909 (fax)
29 April 2003
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Per Title 21 CFR 807 . 92, the following is the 510(k) Summary for the Rational Imaging PACS manufactured and marketed by Intuitive Imaging Informatics, LLC under the trade-name
SUBMITTER: (1)
Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061
818-347-8919 (phone) 818-347-8909 (fax)
CONTACT:
Donald Mundt Manager, Regulatory Affairs Intuitive Imaging Informatics, LLC 30 Hackamore Lane Suite 4 Bell Canyon, CA 91307-1061
818-347-8919 (phone) 818-347-8909 (fax)
29 April 2003 SUBMISSION DATE:
(2) DEVICE NAME:
Rational Imaging PACS TRADE NAME:
- CLASSIFICATION NAME: (per regulation 21 CFR 892.2030) (Class II device) Picture Archiving and Communication System
PRODUCT CODE: LLZ
PREDICATE DEVICE: (3)
Intuitive Imaging Informatics claims Substantial Equivalence to the following device:
| Manufacturer | Trade Name | 510(k) Number | Decision Date |
|---|---|---|---|
| Algotec Systems Ltd. | MediSurf | K971347 | 07-03-1997 |
DEVICE DESCRIPTION: (4)
Rational Imaging PACS is designed for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, CR, MRI, NM, DR, US, Angio, nuclear medicine, and secondary capture devices
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such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed, sent to and retrieved by radiologists at remote sites, stored, archived or printed. Multi-planar Reconstruction (MPR). Anatomic Triangulation (AT) and 3D display are optionally available.
(5) INTENDED USE OF DEVICE
The Rational Imaging PACS is intended to be used in a Radiological Laboratory or Doctors office to allow the medical professionals to retrieve and review exam images at various rotations and options, add patient identification and compress the image using industry accepted techniques. Lossy and lossless compressed images are encapsulated in DICOM v3.0 format, which then may be transmitted via various communication protocols to other sites or archived by a PACS host.
SUBSTANTIAL EQUIVALENCE TO PREDICATE DEVICE (6)
The proposed Rational Imaging PACS, with MPR, AT options, and the predicate device MediSurf are both software suites that process DICOM compliant images and provide a standard set of features pertaining to image processing, archiving and networking. The image manipulation tools and storage techniques are essentially comparable. Workstations are technologically the same with some differences in media type for archival storage. Compression algorithms are different but accomplish the same results. Both products operate on commercially available equipment and are available as either a hardware/software package or software only.
(7) SAFETY
The potential hazards are identified and controlled by a risk management plan. The plan consists of a risk management summary, a software development and validation process, a software verification plan and conformance to Federal Regulations and Industry Standards.
(8) CONCLUSION
The Rational Imaging PACS DICOM compliant imaging system acquires, processes, archives and distributes images over the Internet utilizing similar techniques and functions as the predicate device MediSurf.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines extending from its head, resembling feathers or wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2003
Mr. Donald Mundt Manager, Regulatory Affairs Intuitive Imaging Informatics, LLC 30 Hackamore Lane, Suite 4 BELL CANYON CA 91307-1061
Re: K031473
Trade/Device Name: Rational Imaging PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system
Regulatory Class: II Product Code: 90 LLZ Dated: September 2, 2003 Received: September 4, 2003
Dear Mr. Mundt:
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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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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510(k) Number (if known): _ KO31473
Device Name: Rational Imaging PACS
Indications for Use
Rational Imaging PACS is intended for use by a physician or other medical professionals in the acquisition of medical images and demographic detail from all institutional imaging modalities, including CT, MRI, NM, DR, US, nuclear medicine, Angio and secondary capture devices such as film digitizers or other imaging sources. The acquired medical images and demographic information may be displayed, processed, reviewed optionally utilizing Multi-planar Reconstruction (MPR), Anatomic Triangulation (AT) and 3D display, sent to and retrieved by radiologists at remote sites, stored, archived or printed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number_
Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) OR
Over-the-Counter Use
47