(62 days)
Not Found
No
The summary describes a standard PACS system for image management and manipulation, with no mention of AI or ML capabilities.
No
The device is described as receiving, communicating, processing, manipulating, enhancing, storing, and displaying digital images and data, primarily for viewing and networking medical images. It does not exert any direct therapeutic action or provide treatment.
No
The provided information states that the device receives, processes, stores, and displays digital images and data. While it handles medical images, the description does not indicate that the device itself performs diagnostic interpretations or provides diagnostic conclusions on the images. It functions as an image management and viewing system, which supports diagnostic processes performed by trained professionals, rather than being a diagnostic device itself.
Yes
The device description explicitly states that IntelePACS™ is comprised of "software modules" and describes its functions as receiving, processing, manipulating, enhancing, storing, and displaying digital images and data. While it interacts with hardware (scanners, workstations), the device itself, as described, is the software system.
Based on the provided information, IntelePACS™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- IntelePACS™ Function: The description of IntelePACS™ clearly states its purpose is to receive, process, store, and display digital images from various medical imaging modalities (CT, MR, ultrasound, etc.). It deals with images of the body, not with analyzing biological specimens in vitro (outside the body).
The device's function aligns with a Picture Archiving and Communication System (PACS), which is a common type of medical device used in radiology and other imaging departments.
N/A
Intended Use / Indications for Use
IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F units, computer & 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
Typical users of this system are 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): 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
Ko 3 2533
OCT 1 6 2003
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 29, 2003
Submitter's Information: 21 CFR 807.92(a)(1)
Intelerad Medical Systems Inc. Richard Rubin, Executive Vice President, R&D 460 Ste-Catherine West, Suite 210 Montreal, QC Canada H3B 1A7 Tel: 514.931.6222 Fax: 514.931.4653
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | IntelePACS™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Name: | System, Image Processing |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification
| Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Requlation Number | 892.2050 |
| 510(k) Number | K023460 |
| Device Name | PACSPLUS |
| Applicant | MEDICAL STANDARD CO., LTD. |
| Product Code | LLZ |
| Date Received | 10/15/2002 |
| Decision Date | 01/09/2003 |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory | |
| Committee | Radiology |
| Review Advisory | |
| Committee | Radiology |
Device Description: 21 CFR 807 92(a)(4)
IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to
1
IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
Indications for Use: 21 CFR 807 92(a)(5)
IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. 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 IntelePACS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
IntelePACS™ system 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 shows a logo with a stylized bird figure. The bird is composed of three curved lines that suggest movement or flight. The logo is encircled by text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES'.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2003
Intelerad Medical Systems, Inc. % Mr. Carl Alletto 1100 Lakewood Blvd. DENTON TX 76208
Re: K032533
Trade/Device Name: IntelePACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 29, 2003 Received: August 15, 2003
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 (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.
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 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
4
(Indications for Use Form)
510(k) Number: Ko3 2533
Device Name:
IntelePACS™ from Intelerad Medical Systems Inc.
Indications for Use:
IntelePACS™ is a device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
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
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Nancy C. Brogdon
and Radiological Devices 510(k) Numb