(38 days)
Not Found
Not Found
No
The summary describes a film digitizer and does not mention any AI or ML capabilities, image processing beyond digitization, or performance studies related to algorithmic analysis.
No.
The device is a film digitizer intended for converting analog medical x-ray films to digital images for review, analysis, storage, and display, which are diagnostic support functions, not therapeutic.
No
The device description explicitly states that it is "not as the sole basis for screening or diagnosis" and "not for primary image diagnosis." It is intended for digitizing images for review, analysis, storage, and display.
No
The device description explicitly states "Film Digitizer, Model 2908 Mammo Pro," which implies a physical hardware component used to convert analog films to digital images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Model 2908 Mammo Pro is a film digitizer. Its function is to convert analog medical x-ray films (specifically mammography images) into digital images.
- Intended Use: The intended use clearly states it's for "covering analog Medical x-ray films to digital images" and for "digitization of mammography Imaged for review and analysis," "storage and display." It explicitly states it's "not as the sole basis for screening or diagnosis" and "not for primary image diagnosis."
The device is processing existing images, not analyzing biological samples from a patient. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LMA
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray films
Anatomical Site
mammography
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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Page 2 -
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
2
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