(37 days)
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Not Found
No
The summary describes a digital recorder for capturing and storing images, with no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics associated with AI/ML algorithms.
No
The device is described as a medical digital recorder for capturing and digitizing images in radiology applications, and not as providing any therapeutic function or treatment.
No
The device is a digital recorder used to capture, digitize, and record images from radiology applications onto discs. It does not perform any diagnostic analysis or interpretation of these images.
No
The device description explicitly states "Medical Digital Video Recorder," implying a hardware component for recording and digitizing images. The intended use also describes capturing and digitizing images to physical media (CD/DVD), which requires hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "capture and digitize images and record them" in Radiology applications. This describes a device that handles and stores medical images, not a device that performs tests on biological samples to diagnose conditions.
- Device Description: "Medical Digital Video Recorder" aligns with the image handling function, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing diagnostic information based on laboratory tests
This device appears to be a medical imaging accessory used for recording and archiving images generated by other diagnostic modalities (like X-ray, CT, MRI, etc.).
N/A
Intended Use / Indications for Use
The NAI Tech Products Medical Digital Recorder is intended for use in recording video productions of capture and digitize images and record them to single of multiple in the form of CD (Compact Disc) or DVD (Digital Video Disc).
Product codes
90 LMA
Device Description
Medical Digital Recorder, Video
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Video
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
Image /page/0/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its body, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
NAI Technology Products % Mr. Robert E. Johnson President Diagnostic Data, Inc. 1342-D North Benson Avenue UPLAND CA 91786
Re: K042484
Trade/Device Name: Medical Digital Video Recorder Regulation Number: 21 CFR 892.2030 Regulation Name: Medical imager digitizer Regulatory Class: II Product Code: 90 LMA Dated: September 13, 2004 Received: September 13, 2004
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave icenced your becaller been) processor (is) problem (for the indications for use stated in above and nave determined with the devices marketed in interstate commerce prior to the enclosure) to tegary markedd production Device Amendments, or to devices that have been May 20, 1770, the chactinent acto of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordantee with the proval application (PMA). You may, therefore, market the do for require approval or a premants approvisions of the Act. The general controls provisions of the Act device, subject to the general ventual 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 If your device is classilled (200 additional controls. Existing major regulations affecting your Apploval), it the 70 Subject to activederal 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 FIEast oc advised mart 1271 5 issualled by device complies with other requirements of the Act or any FDA has made a determination and Joan and Jose Federal agencies. You must comply with all the I cacal statues and regulations and limited to registration and listing (21 CFR Part 807); labeling Act S requirements, mediating practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and by the FDA finding of substantial equivalence of your device to a legally premaince notification - ensults 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 rr you declie of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
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 Statement Original 510(k) Submission Indications for OSE Oxatoristration Number 2938727 NAT Tech Products, Registration Name
Device Name/Model: Medical Digital Recorder, Video
NAI Tech Products Applicant: 12919 Earhart Avenue Auburn CA 95602 Adban Number: 2938727
to be assigned by FDA 510(k) Number:
Medical Digital Recorder, Video Device Name:
The NAI Tech Products Medical Digital Recorder is Indications for use: The NAT Foor Productions of capture and digitize intended for ass in Reo images and record them to single of makiple in the form of CD (Compact Disc) or DVD (Digital Video Disc).
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Boydon
Division Sign Off
(Division Sian-Off Division of Reproductive, Abdomi and Radiological Devices 510(k) Number
Prescription use
Per 21 CFR 801.109