(26 days)
The Konica Laser Imager DRYPRO model 771 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.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical image hardcopy device, the "Konica Laser Imager DRYPRO model 771." It does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It details regulatory information and contact points but does not describe any performance studies, data provenance, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the specific information about acceptance criteria and a detailed study as this information is not present in the provided document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2003
Konica Medical and Graphic Corp. % Mr. Shinichi Yamanaka Cosmos Corporation Business Section 319 Akeno, Obata-cho Watarai-gun, Mie-ken JAPAN
Re: K032681 Trade/Device Name: Drypro Model 771 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: 90 LMC Dated: August 7, 2003 Received: September 2, 2003
Dear Mr. Yamanaka:
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 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon
Nancv 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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510(k) Number (If known): Not known 4032481
Device Name: Konica Laser Imager DRYPRO model 771
Indications for Use:
The Konica Laser Imager DRYPRO model 771 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
Prescription Use $\surd$
OR Over The Counter Use
(Optional Format 1-2-96)
David A. Segerson
(Division Sign-Off) Division of Reproductive and Radiological Dev 510(k) Number
§ 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.