(15 days)
Not Found
No
The description focuses on the monitor and software for optimizing display, with no mention of AI/ML terms or functionalities like image analysis or diagnosis support beyond simple display.
No
The device is a monitor system for displaying medical images, not for providing therapy.
No.
The device is a monitor system for displaying medical images; it does not perform any diagnostic function itself, but assists medical practitioners in diagnosis.
No
The device description explicitly states it consists of an AMLCD monitor and a high-resolution graphic control board, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing digital medical images for review, analysis, and diagnosis." This is related to medical imaging, not the analysis of biological samples (blood, urine, tissue, etc.) which is the core of IVD.
- Device Description: The device is a "flat panel hi-resolution AMLCD monitor system" and a "high-resolution graphic control board." These are display and control components, not devices designed to perform tests on biological specimens.
- Mentions image processing: While it mentions "IMAGE PROCESSING," this is in the context of processing medical images for display, not processing biological samples.
- No mention of biological samples or testing: There is no indication that this device interacts with or analyzes any biological materials.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to display images generated by other medical devices (like PACS workstations), not to perform diagnostic tests itself.
N/A
Intended Use / Indications for Use
The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis by trained medical practitioners. This device must not be used in primary image diagnosis in mammography.
Product codes
LLZ
Device Description
The Planar Dome® EX line Model Dome® E2c is a flat panel hi-resolution AMLCD monitor system for displaying medical images. The system consists of an AMLCD monitor and a high-resolution graphic control board that connects to a PACS workstation for image display. The controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images. CXtra is user-friendly software, the purpose of which is to optimize the display for DICOM-compliant viewing.
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
trained medical practitioners / Not Found
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)
The Planar Dome® EX line Model Dome® E2c has been tested to various Standards and was validated for its intended use.
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
Image /page/0/Picture/1 description: The image shows a close-up of a document with the word "PLANAR" at the top. Below the word "PLANAR" is a number that appears to be "2061018". The image is cropped, focusing on these elements, and the overall quality suggests it might be a scan or a photograph of a document.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Summary Date: | 2 March 2006 |
|---|---|
| 21 CFR 807.92(a)(1) | |
| Submitter's Information: | Mr. Craig Harshman |
| Planar Systems, Inc. | |
| 1195 NW Compton Drive | |
| Beaverton, OR 97006-1992 | |
| (503) 748-4661 (Phone) | |
| (503) 748-1244 (fax) | |
| craig_harshman@planar.com (Email) | |
| 21 CFR 807.92(a)(2) | |
| Device Trade Name | |
| Device common Name: | |
| Device Classification Name: | Planar Dome® EX line Model Dome® E2c |
| SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | |
| 892.2050 Picture archiving and communications system | |
| Classification Product Code | LLZ |
| Establishment Registration Number: | 1226517 |
| Device Class: | Class II |
| Classification Advisory Committee: | Radiology |
| 21 CFR 807.92(a)(3) | |
| Predicate Devices: | The predicate devices: |
| 510(k) Number: K052352 | |
| Decision Date: 09/30/2005 | |
| BARCOView, Color Coronis 2MP-21" | |
| 21 CFR 807.92(a)(4) | |
| Device Description: | The Planar Dome® EX line Model Dome® E2c is a flat panel hi- |
| resolution AMLCD monitor system for displaying medical images. | |
| The system consists of an AMLCD monitor and a high-resolution | |
| graphic control board that connects to a PACS workstation for image | |
| display. The controller board is installed into the PACS workstation | |
| computer or other computer system used to display PACS medical | |
| images. CXtra is user-friendly software, the purpose of which is to | |
| optimize the display for DICOM-compliant viewing. | |
| 21 CFR 807.92(a)(5) | |
| Intended Use: | The Planar Dome® EX line Model Dome® E2c is intended to be used in |
| displaying and viewing digital medical images for review, analysis, | |
| and diagnosis by trained medical practitioners. This device must not | |
| be used in primary image diagnosis in mammography. | |
| 21 CFR 807.92(a)(6) | |
| Substantial Equivalence: | The Planar Dome® EX line Model Dome® E2c is substantially equivalent to |
| the BARCOView, Color Coronis 2MP-21" | |
| (K052352) in that: | |
| The subsection of the system are similar in that they each consist of: | |
| ● | |
| Display Monitor |
1
- Graphic controller card installed in a PACS or PC. ୍
- o Software
- . Intended use is same
- . Performance attributes are similar
- Follow DICOM PS3.14 "Grayscale Standard Display Function" .
This 510(k) Premarket Notification for the Planar Dome® EX line Model Dome® E2c contains adequate information and data to enable FDA CDRH to determine substantial equivalence to the predicate device.
The Planar Dome® EX line Model Dome® E2c has been tested to various Standards and was validated for its intended use.
The Planar Dome® EX line Model Dome® E2c will be manufactured in accordance with voluntary and safety standards.
This submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
21 CFR 807.92(b) Conclusions and Statements:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 8 2006
Planar Systems, Inc. % Mr. Marc M. Mouser Senior Project Engineer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607
Re: K061018
Trade/Device Name: Planar Dome® EX line Model Dome® E2c Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 5, 2006 Received: April 13, 2006
Dear Mr. Mouser:
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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo. The logo is a circular seal with the words "FDA Centennial" in the center. The years "1906-2006" are at the top of the seal. Below the seal is the text "Protecting and Promoting Public Health" in a decorative font.
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 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
2-5
PLANAH
Indications for Use
510(k) Number (if known): צו בי במצ
Device Name:
Planar Dome® EX line Model Dome® E2c Indications for Use:
The Planar Dome® EX line Model Dome® E2c is intended to be used in displaying and viewing digital medical images for review, analysis, and diagnosis by trained medical practitioners.
This device must not be used in primary image diagnosis in mammography.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of -1
(Posted November 13, 2003)
David H. Aronson
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number