(125 days)
Not Found
No
The summary describes a standard medical display device with no mention of AI/ML capabilities or related performance studies.
No
The device is a display for viewing digital images, not a tool for treatment or diagnosis.
No
The device is a display system used for viewing digital images by medical practitioners, but its intended use statement explicitly states it is "not intended for and should not be used for primary diagnosis in digital mammography." This indicates it is not a diagnostic device in itself.
No
The device description explicitly states it is a "Digital Monochrome LCD flat panel display," which is a hardware component.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Clinton Electronics Corp. DL Series II Flat-Panel Displays are described as devices for displaying and viewing digital images. They are essentially monitors used by medical practitioners to look at medical images.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or any other activity typically associated with in vitro diagnostics.
The device is a medical display intended for viewing medical images, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Clinton Electronics Corp. DL Series II Medical Flat Panel Display are intended for use in displaying Medical Images for review by trained Medical Practitioners.
The Clinton Electronics Corp. DL Series II Flat-Panel Displays are intended for use in displaying and viewing digital images by trained medical practitioners. The Displays are not intended for and should not be used for primary diagnosis in digital mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The DL Series II Displays are Digital Monochrome LCD flat panel displays. The series II are capable of Displaying 2 mega-pixel and 3 mega-pixel formats dependent upon model type.
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
trained Medical Practitioners
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
- TO: Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
- FROM: Randall Schroedl Clinton Electronics Corp.
- February 2, 2006 DATE:
REF: K053039
Please find attached the information requested in your 1-26-06 follow up letter
Regards,
Randall Schroedl
Image /page/0/Picture/10 description: The image shows the characters 'K' and '15' written in black ink on a white background. The 'K' is written in cursive, while the '15' is written in block numerals. The characters are slightly tilted to the right.
1
REF: K053039
Additions to Section 4.0:
4.4 Intended Use:
The Clinton Electronics Corp. DL Series II Medical Flat Panel Display are intended for use in displaying Medical Images for review by trained Medical Practitioners.
4.5 Device Description Summary:
The DL Series II Displays are Digital Monochrome LCD flat panel displays. The series II are capable of Displaying 2 mega-pixel and 3 mega-pixel formats dependent upon model type. Refer to section 5.2.1 for further details
Additions to Section 5.0
5.3 Predicated Device Equivalence:
Example #1: (3 meg format)
Regulation Number: 892.2050 510(K) number: K032638 Device Name: Dome CX Digital Flat Panel Display System Models C3 Gray Applicant: Planar Systems, Inc. 400 Fifth Ave Waltham, MA 02451 Product Code: LLZ Decision Date: September 11, 2003
Example #2: (2 meg format)
Regulation Number: 892.2050 510(K) number: K042660 Device Name: NIO 2MP Medical Flat Panel Display System Applicant: Barco NV Barcovie 12200 Academy Road NE #931 Albuquerque, NM 87111 Product Code: LLZ Decision Date: November 19, 2004
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and features an abstract eagle design in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged around the perimeter of the circle.
Public Health Service
MAR I 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Randall J. Schroedl Director of Engineering Clinton Electronics Corp. 6701 Clinton Road LOVES PARK IL 61111
Re: K053039 Trade/Device Name: DL series II Digital Flat-Panel Displays, Models: DL2XXX and DL3XXX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 14, 2006 Received: February 17, 2006
Dear Mr. Schroedl:
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.
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 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/industrv/support/index.html.
Sincerely vours.
Nancy C. Buxton
Nanev 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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K053039/S2
Indications for Use
510(k) Number: K053039
Device Name:
DL SERIES II DIGITAL FLAT-PANEL DISPLAYS, Models DL2XXX and DL3XXX from Clinton Electronics Corp.
Indications for Use:
The Clinton Electronics Corp. DL Series II Flat-Panel Displays are intended for use in displaying and viewing digital images by trained medical practitioners. The Displays are not intended for and should not be used for primary diagnosis in digital mammography.
Prescription Use AND/O Over-The-Counter Use (Part 21 CFR 801 Subpart D) R (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)
Nancy C. Hoagdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K053039