(85 days)
The LR5200 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.
No changes in hardware or software are being implemented to the currently marketed LR5200. The present 510(k) is only for a clarification in the indications for use. The LR5200 is a laser (He-Ne) film recorder designed to produce high quality gray scale diagnostic medical images when interfacted to a host imaging device or PACS system. The LR5200 uses a wet process for developing the medical images.
The provided text is a 510(k) summary for the Agfa LR 5200 Laser Film Recorder. Upon review, it's clear that this submission is not for a new device requiring performance testing against acceptance criteria. Instead, it's a clarification of the indications for use for an already legally marketed device (K964414).
Therefore, no acceptance criteria or study data demonstrating device performance are provided in this document. The key statements confirming this are:
- "No changes in hardware or software are being implemented to the currently marketed LR5200."
- "The present 510(k) is only for a clarification in the indications for use."
- "No additional testing was carried out for this premarket notification since the device is already indicated for the same uses."
- "The LR 5200 Laser Film Recorder has the same (identical) technological characteristics as the predicate device."
Because this submission is an amendment regarding indications for use and explicitly states "No additional testing was carried out," the request for details on acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for testing and training cannot be fulfilled from this document.
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510(k) Summary
LR 5200 Laser Film Recorder
K0/2010
Page 1 of 2
Classification Name: Medical Image Hard Copy Device 21 CFR 892.1140
Agfa Corporation 10 South Academy Street Greenville, SC 29602-9048
Contact: Jeff Jedlicka, Prepared: June 20, 2001
LEGALLY MARKETED PREDICATE DEVICES A.
The LR5200 was cleared for marketing through the premarket notification K964414 on January 27, 1997. The LR5200 with revised indications for use statement is substantially equivalent to the currently marketed LR 5200.
DEVICE DESCRIPTION B.
No changes in hardware or software are being implemented to the currently marketed LR5200. The present 510(k) is only for a clarification in the indications for use. The LR5200 is a laser (He-Ne) film recorder designed to produce high quality gray scale diagnostic medical images when interfacted to a host imaging device or PACS system. The LR5200 uses a wet process for developing the medical images.
C. INTENDED USE
The present LR5200 is currently indicated for the printing of digital medical images and it is also currently indicated for printing of images from several specific imaging modalties, including mammography. The clarification to the indications for use will make it explicit that the device is indicated for the printing of digital mammography images.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The LR 5200 Laser Film Recorder is a medical device, and it has very similar indications for use as the legally marketed predicate device. The LR 5200 Laser Film Recorder has the same (identical) technological characteristics as the predicate device. This premarket notification has described the characteristics of the LR 5200 Laser
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Koforo
faye 2 of 2
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Film Recorder in sufficient detail to assure substantial equivalence
E. TECHNOLOGICAL CHARACTERISTICS
No changes in hardware or software are being implemented to the currently marketed LR5200, so the technological characteristics are identical.
F. TESTING
No additional testing was carried out for this premarket notification since the device is already indicated for the same uses.
G. CONCLUSIONS
This 510(k) has demonstrated substantial equivalence to the predicate device.
l The meaning of the terms "substantial equivalence" and "substantially equivalent" as used in this 510(k) is limited to the way they are defined in, and used by FDA in accordance with, Sections 513(f)(1) and 513(l)(1) of the Federal Food, Drug, and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2001
Agfa Corporation % T. Whit Athey, Ph.D. Senior Consultant C. L. McIntosh 12300 Twinbrook Pkwy Suite 625 ROCKVILLE MD 20850
Re: K012010
Trade/Device Name: LR 5200 Laser Recorder Regulation Number: 21 CFR 892.2040 Regulation Name: Medical Image Hard Copy Device Regulatory Class: II Product Code: 90 LMC Dated: June 27, 2001 Received: June 27, 2001
Dear Dr. Athey:
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 11 you tten office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). Other general information on of reference to prise 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. Hogdon
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): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The LR5200 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)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nancy C Inogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K012010
§ 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.