(88 days)
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No
The summary describes a laser imager that converts and prints data, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions or performance studies related to AI/ML.
No
This device is described as a laser imager that converts data from diagnostic equipment into images on film. It does not perform any therapeutic function.
No
The device converts data from diagnostic equipment into images, but it does not perform diagnosis itself.
No
The device description explicitly states it is a "laser imager," which is a hardware device used for printing medical images.
Based on the provided information, the Konica Laser Imager DRYPRO model 722 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device converts data from diagnostic equipment and prints it onto film. This is a function related to medical imaging and documentation, not the analysis of biological samples (which is the core of IVD).
- Device Description: It is described as a "laser imager," which aligns with its function of printing images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances in the body, or providing diagnostic information based on in vitro testing.
Therefore, the Konica Laser Imager DRYPRO model 722 falls under the category of a medical imaging peripheral or output device, not an IVD.
N/A
Intended Use / Indications for Use
The Konica Laser Imager DRYPRO model 722 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.
Product codes
90 LMC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, DSA, and other medical devices
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The words are arranged on a single line. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1999
Konica Corporation C/O Shinichi Yamanaka Cosmos Corporation 319 Akeno, Obata-cho, Watarai-gun Mie-ken, 519-05 JAPAN
RE:
K992586 DRYPRO Model 722 Laser Imager Dated: July 23, 1999 Received: August 2, 1999 Regulatory Class: II 21 CFR 892.2040/Procode: 90 LMC
Dear Mr. Yamanaka:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 Cosmelic Act (Act). 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. Iisting 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any oblication you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CART Daniel C. O'Reilly, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
510(k) Number (If known): Not known
Device Name: Konica Laser Imager DRYPRO model 722
Indications for Use:
The Konica Laser Imager DRYPRO model 722 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
t
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
OR Over-The-Counter Use
(Optional Format 1-2-96)