(51 days)
Not Found
No
The summary describes standard image processing and data management functions, with no mention of AI, ML, or related concepts.
No
The device is described as imaging software used for quality control operations on medical images, not for treating any medical conditions.
No
The device is described as software used for quality control operations on imaging studies (e.g., scanning, capturing, editing, renumbering images), not for interpreting images to diagnose a medical condition.
No
The device description explicitly mentions "digitizing film images" and "capturing video images," which implies the use of hardware components (scanners, video capture devices) that are part of the overall system, even if the submission focuses on the software.
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 PacsSCAN Medical Imaging Software with QC Module is described as performing quality control operations on imaging studies (scanned film images, captured video images). It manipulates and manages existing medical images and associated data.
- Lack of Biological Sample Analysis: The device does not analyze biological samples from a patient. Its input is image data, not biological material.
The device is clearly focused on the management and quality control of medical images, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
Product codes
LLZ
Device Description
The PacsSCAN Medical Imaging Software with OC Module is intended to be used by authorized staff to perform various quality control operations on PacsSCAN imaging studies before they are made available to other locations in the network. These operations include digitizing film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
Mentions image processing
Yes
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
authorized staff
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)
Software validation has established the device's ability to meet its intended use and established specifications.
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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.
Submitter Information:
PACSGEAR, Inc. 7020 Koll Center Pkwy. Suite 100 Pleasanton, CA 94566
JAN 2 8 2009
Date Summary Prepared:
July 2, 2008
Contact Person:
Ian P. Gordon Emergo Group, Inc. Telephone: 512-327-9997 Fax: 512-327-9998
Device Name:
Trade Name(s): PacsSCAN Medical Imaging Software with QC Module Classification Name: Image Processing System Classification Regulation: 892.2050 Panel: Radiology Product Code: LLZ
Predicate Device Information:
Device Name: RadWorks Medical Imaging Software with Quality Control Module Manufacturer: Applicare Medical Imaging, B.V. Reference: K982862
Device Description:
The PacsSCAN Medical Imaging Software with OC Module is intended to be used by authorized staff to perform various quality control operations on PacsSCAN imaging studies before they are made available to other locations in the network. These operations include digitizing film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
Intended Use:
The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images. combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
1
| Specification | PACSGEAR Medical
Imaging Software | RadWorks Medical
Imaging Software |
|--------------------------------------------------------------|------------------------------------------------|--------------------------------------|
| Digitize film | Yes | Yes |
| Capture video | Yes | Yes |
| Edit patient demographics | Yes | Yes |
| Review reports/study
history | Yes | Yes |
| Add/remove images | Yes | Yes |
| Combine studies | Yes | Yes |
| Renumber Images | Yes | Yes |
| Edit patient orientation
information | Yes | Yes |
| Set/edit routing information | Yes | Yes |
| Image review | Flip/Rotate/Pan/Zoom | Flip/Rotate/Pan/Zoom |
| JPEG lossy/lossless
compression | Yes and JPEG2000
lossy/lossless compression | Yes |
| LUT compensation | Yes (automatic) | Yes (manual) |
| Image processing (image
segmentation, image
smoothing) | Yes | Yes |
| DICOM Print | Yes | Yes |
Comparison to Predicate Device:
Testing and Conclusions:
Software validation has established the device's ability to meet its intended use and established specifications.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PACSGEAR, Inc. JAN 2 8 2009 c/o Mr. Ian Gordon Senior Vice President Emergo Group, Inc. 1705 S. Capitol of Texas Highway, Suite 500 AUSTIN TX 78746
Re: K083618
Trade/Device Name: PacsSCAN Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2008 Received: December 9, 2008
Dear Mr. Gordon:
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 (PMA), 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.
3
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-011 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-011 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-012 |
| Other | (240) 276-010 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.support/ind/subml/
Sincerely yours.
Janine M. Morris
Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 1083618
Device Name: PacsSCAN Medical Imaging Software with QC Module
Indications for Use: The PacsSCAN Medical Imaging Software with QC Module is intended to be used by authorized staff to perform various quality control operations on PACSGEAR imaging studies before they are made available to other locations in the network. These operations include scanning film images, capturing video images, confirming or editing patient demographics, reviewing the history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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 a Radiological Devices 510(k) Number