NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER

K042484 · Nai Technology Products · LMA · Oct 20, 2004 · Radiology

Device Facts

• Record ID: K042484
• Device Name: NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER
• Applicant: Nai Technology Products
• Product Code: LMA · Radiology
• Decision Date: Oct 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The NAI Tech Products Medical Digital Recorder is intended for use in the capture and digitize of video images and record them to single or multiple in the form of CD (Compact Disc) or DVD (Digital Video Disc).

Device Story

Device captures and digitizes video signals; records output to CD or DVD media. Used in clinical settings to archive medical video imagery. Operated by healthcare professionals. Provides digital storage of visual data for review and documentation purposes; facilitates clinical record-keeping and patient data management.

Clinical Evidence

bench testing only

Technological Characteristics

Digital video recording system; inputs analog/digital video signals; outputs to CD/DVD optical media. Standalone device.

Indications for Use

Indicated for the capture and digitization of video images for recording onto CD or DVD media.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*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.

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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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