(28 days)
Not Found
No
The description focuses on hardware modifications for image transmission and control, with no mention of AI/ML algorithms or functions.
No
The device is described as a Laser Film Recorder used for printing diagnostic quality medical images, which aids in physician diagnosis. It does not perform any therapeutic function.
No
The device is a laser film recorder used for printing medical images for aid in physician diagnosis, not for directly performing the diagnosis itself.
No
The device description explicitly mentions modifications to hardware components (communications board) and the replacement of a hardware component (MG3000 controller function with a new controller). This indicates it is not a software-only device.
Based on the provided information, the LR 5200 Laser Film Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LR 5200 Function: The LR 5200 is a film recorder that prints medical images generated by various imaging modalities (CT, MRI, Ultrasound, etc.). These modalities produce images of the inside of the body, not from in vitro specimens.
- Intended Use: The intended use clearly states "providing diagnostic quality medical images on film for aid in physician diagnosis," which aligns with imaging devices, not IVDs.
The device's function is to output images from imaging modalities, which are distinct from the laboratory testing performed by IVD devices.
N/A
Intended Use / Indications for Use
The LR DICOM Controller is a part of the LR 5200 Laser Film Recorder system, which is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.
The LR 5200 Laser Film Recorder is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.
Product codes (comma separated list FDA assigned to the subject device)
90 LMC
Device Description
The modification involves replacing the controller function of the currently marketed MG3000 component of the LR5200 system so that a new controller can transmit image information from an Ethernet to the LR 5200 at up to 100 MB/sec. The communications board in the LR5200 will also be modified to accept the new communications approach. The MG3000 will still be used in some applications, e.g., to interface a non-networked imaging modality directly to the LR 5200, or to interface a non-DICOM modality to a network.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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 modified LR DICOM Controller has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(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). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
11022658
6 2002 510(k) Summary SEP
LR DICOM Controller
Common/Classification Name: Medical Image Hard Copy Device 21 CFR 892.2040
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeff Jedlicka; Prepared: August 9, 2002
LEGALLY MARKETED PREDICATE DEVICES A.
The predicate device is the LR 5200 Printer and Controller, which was cleared originally by FDA on 5 November 1996 as K964414 and also with clarified indications on 27 June 2001 as K012010.
B. DEVICE DESCRIPTION
The modification involves replacing the controller function of the currently marketed MG3000 component of the LR5200 system so that a new controller can transmit image information from an Ethernet to the LR 5200 at up to 100 MB/sec. The communications board in the LR5200 will also be modified to accept the new communications approach. The MG3000 will still be used in some applications, e.g., to interface a non-networked imaging modality directly to the LR 5200, or to interface a non-DICOM modality to a network.
C. INTENDED USE
The LR DICOM Controller is a part of the LR 5200 Laser Film Recorder system, which is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The modified LR 5200 Printer/Controller has the same indications for use as the legally marketed predicate device. The modified device
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has the same technological characteristics as the currently marketed This premarket notification will describe most of the device. characteristics of the modified LR DICOM Controller in sufficient detail to assure substantial equivalence. For the few characteristics that may not be precise enough to ensure equivalence, performance data or certifications are provided.
E. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics are the same in the proposed and predicate devices.
F. TESTING
The modified LR DICOM Controller has been tested for proper performance to specifications through various in-house reliability and imaging performance demonstration tests.
G. CONCLUSIONS
This pre-market submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jeff Jedlicka Manager of Regulatory Affairs Agfa Corporation 10 South Academy Street Mail Stop 100 GREENVILLE SC 29601
Re: K022658
Trade/Device Name: LR DICOM Controller Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 7, 2002 Received: August 9, 2002
Dear Mr. Jedlicka:
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,
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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 nredicate 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:
| 8xx.1xxx | (301) 594-459- |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-461- |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-461- |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-465- |
| Other | (301) 594-469- |
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 Part 807.97). 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. Snigdon
Nancy 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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): 长۵2 - 2658
Device Name:
Indications For Use:
The LR 5200 Laser Film Recorder is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vernil C. Bergman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
:
Over-The-Counter Use