(105 days)
Not Found
No
The description focuses on the device's function as a digitizer and scanner, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device digitizes radiographs and paper reports, which is for diagnostic use (storing and viewing images) rather than applying therapy or treatment to a patient.
No
The device digitizes existing radiographic films and paper reports; it does not generate new data for diagnostic purposes. Its digital output is intended for "primary, secondary and over reading applications" of existing X-ray film, and it is explicitly stated "This device is not to be used for primary image diagnosis in mammography."
No
The device description explicitly states it is a "transparency film digitizer and paper CCD scanner," which are hardware components used to digitize physical films and documents.
Based on the provided information, the Medi-6000 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.
- Medi-6000 Function: The Medi-6000 digitizes radiographic films (X-rays) and paper reports. It works with images and documents, not biological samples.
- Intended Use: The intended use is for digitizing existing medical images and reports for storage and viewing, not for performing diagnostic tests on patient samples.
Therefore, the Medi-6000 falls under the category of medical imaging devices or document management systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.
Product codes (comma separated list FDA assigned to the subject device)
LMA
Device Description
The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients, hospitals, and office records. It can capture details in bright and dark areas of x-ray films and provide the medical professionals a convenient method to digitize the roentgenogram for the electric data storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray film
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals or trained staffs.
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)
The performance testing results for the Medi-6000 digitizer demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a component of a PAC or Teleradiology system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
[As required by section 807.92(c)]
- Submitter: Microtek International, Inc. 6, Industry East Road 3, Science-Based Industrial Park, Hsinchu, 30077, Taiwan, TEL: +886-3-5772155 FAX: +886-3-5772598
-
- Official Correspondent: Mr. George Sun
-
- Date of 510(k) Submittal: 29. April, 2009
-
- Device Trade Name Medi-6000 Medical Image Digitizer
-
- Common Name: Film digitizer
-
- Classification Name: Image digitizer was classified in class II (21 CFR 892.2030)
-
- Device Product Code: LMA
-
- Predicate Device: Manufacturer: Howtek Incorporated Device name: Film digitizer Model name: Fulcrum 510(k) No.: K021949
Manufacturer: VIDAR Systems Corporation Device name: X-ray film digitizer Model name: P111, TeleRADPRO, VXR-12 plus 510(k) No.: K993597
-
- Device Description:
The Medi-6000 is a digitizer that can easily transfer x-ray films into a digital format for patients, hospitals, and office records. It can capture
- Device Description:
-3-
P. 1 of 2
1
details in bright and dark areas of x-ray films and provide the medical professionals a convenient method to digitize the roentgenogram for the electric data storage.
-
10.Intended Use:
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. The target users of the device are medical professionals or trained staffs. -
11 Technological Characteristics:
The Medi-6000 with a high optical resolution of 600 dpi, a dynamic range of 4.0 Dmax, and the 16-bit grayscale, the Medi-6000 allows users to get better image details in just seconds. -
12.Performance Testing:
The performance testing results for the Medi-6000 digitizer demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a component of a PAC or Teleradiology system. -
- Substantial Equivalence to Predicate Device:
Medi-6000 is substantially equivalent to Fulcrum and P111. TeleRADPRO, and VXR-12 plus. Medi-6000 employs the resolution values same as that of Fulcrum, and better than P111, TeleRADPRO, and VXR-12 plus. Comparison table of the principal characteristics of these three devices is shown in the Section II and specification data for the Medi-6000 is included in Section I-3.
- Substantial Equivalence to Predicate Device:
14.Conclusions:
In terms of intended use, construction, function, safety, operating environmental conditions and effectiveness of the Medi-6000 film digitizer is substantially equivalent to the predicate devices used for this application.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Microtek International, Inc. % Mr. Hui-chen Kai, Supervisor Electronics Testing Center, Taiwan No. 8, Lane 29, Wenming Rd. Guisan, Taoyuan, 33383 TAIWAN
AUG 1 4 2009
Re: K091288
Trade/Device Name: Medi-6000 Medical Image Digitizer Regulation Number: 21 CFR 892.2030 Regulation Name: Medical image digitizer Regulatory Class: II Product Code: LMA Dated: July 17, 2009 Received: July 22, 2009
Dear Mr. Hui-chen Kai:
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); medical device reporting (reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/cdrh/industry/support/index.html.
Sincerely yours,
Lammy M. Moure
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Not known K091288
Device Name: Medi-6000 Medical Image Digitizer
Indications For Use:
The Medi-6000 consists of a transparency film digitizer and paper CCD scanner that is used to digitize radiographs or X-ray film as well as paper reports or doctor's orders. When the Medi-6000 is used to digitize radiographic films, the digital image is intended for use in primary, secondary and over reading applications. This device is not to be used for primary image diagnosis in mammography. The target users of the device are medical professionals or trained staffs.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number
Lopui Nh Nhay
vision of Reproductive, Abdominal and
P. 1 of|