AMBER DU

K973219 · Oldelft Corp. of America · KPR · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K973219
• Device Name: AMBER DU
• Applicant: Oldelft Corp. of America
• Product Code: KPR · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Amber DU provides the Radiologist the ability to acquire chest images on film, to digitize these images real time for analysis on the Operator Workstation and retain the ability to analyze the films on a conventional lightbox, and to export the digital images Dicom 3 conformant to the hospital's network server for storage and eventual retrieval if desired.

Device Story

Amber DU is a stationary X-ray system for chest imaging. It integrates the Oldelft Amber AU X-ray unit with a Lumisys Lumiscan 75 LASER film digitizer and a Rogan Imaging workstation. The system acquires chest images on film; the digitizer converts these to digital format in real-time. The workstation displays images for radiologist analysis while maintaining the ability to view original films on a conventional lightbox. The system supports DICOM 3 export to hospital network servers for storage and retrieval. Operated by radiologists in clinical settings, the device facilitates digital image management and archival while preserving traditional film-based diagnostic workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stationary X-ray system (21 CFR 892.1680). Components: Oldelft Amber AU X-ray unit, Lumisys Lumiscan 75 LASER film digitizer, and Rogan Imaging workstation. Connectivity: DICOM 3 conformant for network server export. Compliance: 21 CFR 1020.30 and 1020.31.

Indications for Use

Indicated for use by radiologists to acquire chest X-ray images on film, digitize them for workstation analysis, and export DICOM 3 compliant images to hospital network servers.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Reference Devices

• Oldelft Amber AU
• Lumisys Lumiscan 75 LASER Film Digitizer

Submission Summary (Full Text)

{0}------------------------------------------------

## Summary of Safety and Effectiveness

| Device proprietary name: | AMBER DU |
|------------------------------------|-----------------------------------|
| Classification name: | Stationary X-ray System (90-KPR) |
| | OCT - 8 1997 |
| Establishment Registration Number: | 1180516 |
| | Oldelft Corporation of America |
| | 9108 Guilford Road |
| | Columbia, MD 21046 |
| Owner/Operator and Manufacturer: | Oldelft BV |
| | Roentgenweg 1, 2624 BD Delft |
| | P. O. Box 5082, 2600 GB Delft |
| | The Netherlands |
| Establishment Registration No: | 9611894 |
| Owner/Operator Number: | 8030474 |
| Classification: | Class II |
| Product code: | 90-KPR (Stationary X-ray System) |
| CFR Citation: | 21 CFR 892.1680 |
| | Tier I submission |
| Panel: | Radiology |
| Performance standard: | 21 CFR 1020.30 and 21 CFR 1020.31 |
| Accession number: | 8811863 |

The Oldelft Amber DU is comprised of the currently marketed Oldelft Amber AU, the Lumisys Lumiscan 75 LASER Film Digitizer which is commercially available, and a digital workstation based on a commercially available workstation from Rogan Imaging Corporation using software written by Rogan to Oldelft's specifications. The workstation displays screens to the operator for data input and for data and image display. The Oldelft Amber DU display is configured as a shell about the Rogan software which operates in the background to perform essential functions and to provide miniPACS features to Amber DU and allow the importation of patient demographic information and to allow the exportation of digital image data into which patient demographics have been incorporated.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol of three abstract human figures, possibly representing health, help, and services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 8 1997

L Don Phillips Oldelft Corporation of America 9108 Guilford Rd. Columbia, MD 21046

Re: K973219

Amber DU (Chest Unit) Dated: August 25, 1997 Received: August 27, 1997 Regulatory class: II 21 CFR 892.1680/Procode: 90 KPR

Dear Mr. Phillips:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 misbranion.

If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{2}------------------------------------------------

## Statement of indications for use

| 510(k) Number (if known): | (k97) 3219 |
|---------------------------|------------|
|---------------------------|------------|

Device Name: Amber DU

Indications for Use:

Amber DU provides the Radiologist the ability to acquire chest images on film, to digitize these images real time for analysis on the Operator Workstation and retain the ability to analyze the films on a conventional lightbox, and to export the digital images Dicom 3 conformant to the hospital's network server for storage and eventual retrieval if desired.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over the Counter Use

Ulimil A. Segerson

(Optional Formal 1-2-96)

r

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number