(89 days)
Not Found
No
The summary describes a software development kit for image compression algorithms, with no mention of AI or ML.
No
The device is a software development kit for compressing medical image data, not a device that directly treats or diagnoses patients.
No
The device is a software development kit for compressing medical image data, not for diagnosing conditions. It's used by software developers to build applications, not directly by medical professionals for diagnosis.
Yes
The device is explicitly described as a "software development kit" and "software libraries" intended for use by software developers to integrate image compression algorithms into their medical imaging applications. There is no mention of any associated hardware component being part of the submitted device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for software developers to compress data in digital medical images. This is a data processing function, not a diagnostic test performed on biological samples.
- Device Description: It's a software development kit (SDK) for integrating image compression algorithms. It doesn't analyze biological samples or provide diagnostic information about a patient's health status.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic results related to a disease or condition.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. PICTools Medical Compression Toolkit does not fit this description.
N/A
Intended Use / Indications for Use
PICTools Medical Compression Toolkit is intended to be used by software developers in the development of applications for the compression of the data in digital medical images.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
PICTools Medical is a software development kit written in 'C' for software developers to write applications interfaces to integrate particular image data compression algorithms into their medical imaging applications. It provides an array of high performance image compression libraries intended for use by developers of medical devices in the fields of radiology, cardiology, digital dentistry, ultrasound, and telepathology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
software developers
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
SEP 1 4 1998
: 上一篇:
机场 - 2017-04-04
ﮨﭗ -
510 (k) Summary as required by 807.92 9 (c) for PICTools Medical Compression Toolkit Prepared June 8, 1998
| Submitted by: | Pegasus Imaging Corporation
4010 Boy Scout Boulevard
Suite 400
Tampa, Florida 33607-5799
telephone: 813-875-7575 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Andrew Hudson
Director of Business Development |
| Device Trade Name: | PICTools Medical Compression Toolkit |
| Common Name: | Medical Image Compression Software Toolkit |
| Classification: | Picture Archiving and Communications Systems were reviewed by
the Radiology Panel and are classified in Class II per 21 CFR
892.2050. Image compression devices that label all lossily
compressed images as such are being considered by the agency for
exemption from premarket notification requirements [510(k)]. |
| Predicate Devices: | Access Radiology (Framewave) K972925 and WinRad
Teleradiology System (K936179). |
1
Description of Devices:
PICTools Medical is a software development kit written in 'C' for software developers to write applications interfaces to integrate particular image data compression algorithms into their medical imaging applications. It provides an array of high performance image compression libraries intended for use by developers of medical devices in the fields of radiology, cardiology, digital dentistry, ultrasound, and telepathology.
Intended Use of Device:
PICTools Medical Compression Toolkit is intended to be used by software developers in the development of applications for the compression of the data in digital medical images.
Substantial Equivalence to Predicate Device:
The wavelet compression algorithm in PICTools Medical Compression Toolkit is substantially equivalent to that in Access Radiology (Framewave) (K972925). The JPEG compression algorithms in PICTools Medical Compression Toolkit are substantially wquivalent to those in WinRad Teleradiology System (K936179). The clinical functionalities of the three devices are compared below.
| | Wavelet image
compression | JPEG image
compression |
|-------------------------------------------|------------------------------|---------------------------|
| PICTools Medical
Compression Toolkit | X | X |
| Access Radiology
(Framewave) (K972925) | X | |
2
Image /page/2/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 symbol that resembles three overlapping human figures or abstract shapes. The symbol is black, and the text is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 1998
Andrew Hudson Director of Corporate Development Pegasus Imaging Corporation 4010 Boy Scout Blvd., Suite 400 Tampa, FL 33607
Re:
K982146 PICTools Medical Compression Toolkit Dated: June 10, 1998 Received: June 17, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Hudson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmam.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K982146
PICTools Medical Compression Toolkit Device Name:
Indications For Use:
PICTools Medical Compression Toolkit is intended to be used by software developers ITC I ouls Medical Compression Foother is and in digital medical images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal, ENT and Radiological I
510(k) Number K982146
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)