(38 days)
Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images.
The device is indicated for the digitization of mammography Imaged for review and analysis, but not as the sole basis for screening or diagnosis.
The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.
Film Digitizer, Model 2908 Mammo Pro
The provided document is a 510(k) clearance letter from the FDA for a medical image digitizer (Film Digitizer, Model 2908 Mammo Pro). It does not contain details about specific acceptance criteria or a study proving the device meets those criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Therefore, I cannot provide the requested information as the source document does not contain it. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) are typically found in the 510(k) submission document itself, or in associated test reports, which are not part of this clearance letter.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Takashi Inami Manager ARRAY Corp. 3-42-10 Yoyogi Sibuya-ku, Tokyo, 151-0053 JAPAN
DEC 2 1 2006
Re: K063424
Trade/Device Name: Film Digitizer, Model 2908 Mammo Pro Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: LMA Dated: November 6, 2006 Received: November 13, 2006
Dear Mr. Inami:
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.
Image /page/0/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top. Below that is the text "FDA Centennial" in a stylized font. There are three stars at the bottom of the logo. The logo appears to be a commemorative emblem for the 100th anniversary of the Food and Drug Administration.
Protecting and Promoting Public Health
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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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
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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Indications for Use
510(k) Number (if known): K063424
Film Digitizer, Model 2908 Mammo Pro Device Name :
Indications For Use:
Model 2908 Mammo pro is intended for covering analog Medical x-ray films to digital images.
The device is indicated for the digitization of mammography Imaged for review and analysis, but not as the sole basis for screening or diagnosis.
The device is indicated for the digitization of mammography images for storage and display not for primary image diagnosis.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seggern
(Division Sign-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Numb
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). 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.