HELIOS LASER IMAGER 1417
Device Facts
| Record ID | K973028 |
|---|---|
| Device Name | HELIOS LASER IMAGER 1417 |
| Applicant | Sterling Diagnostic Imaging, Inc. |
| Product Code | LMC · Radiology |
| Decision Date | Oct 28, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2040 |
| Device Class | Class 2 |
Indications for Use
The Raven is a free standing device used to print diagnostic images for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
Device Story
Helios Laser Imager 1417 accepts electrical image signals (analog or digital) from imaging modalities like CT or MRI; transforms signals into hard copy diagnostic images on proprietary medical imaging media using laser technology. Device operates as a standalone unit in clinical environments; operated by trained professionals. Incorporates an internal DICOM print server; utilizes dual-laser system for simultaneous printing of two lines of data to increase throughput. Output is reviewed by clinicians on standard view boxes to support diagnostic decision-making. Benefits include elimination of darkroom, film processors, chemical waste, and associated storage requirements.
Clinical Evidence
No clinical data. Device is a modification of a previously cleared predicate. Safety and effectiveness supported by hazard analysis and compliance with international safety standards and ISO9000/21 CFR 820 quality system regulations.
Technological Characteristics
Laser-based imaging system; produces hard copy images on proprietary medical imaging media. Does not use silver halide photographic media. Features integrated DICOM print server and dual-laser printing mechanism. Manufactured in compliance with ISO9000 and 21 CFR 820. No patient-contacting materials.
Indications for Use
Indicated for use by trained professionals to print diagnostic images from medical imaging modalities (e.g., CT, MRI) for viewing on a standard view box in any clinical setting where hard copy output is required.
Regulatory Classification
Identification
A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.
Predicate Devices
- Helios Laser printer (K912073)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for Sterling Diagnostic Imaging. The word "STERLING" is in large, bold, sans-serif font, with the registered trademark symbol next to the "G". Below that, in a smaller font, are the words "Diagnostic Imaging". Above the logo is the number K973028 in a handwritten style.
# OCT 28 1997
### Summary of Safety and Effectiveness
## Helios Laser Imager
| CLASSIFICATION NAME: | Although this device has not been formally classified by FDA, it has been categorized as 90LMC and is regulated as Class II Tier I |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| COMMON/USUAL NAME: | Multi-Format Imager |
| TRADE/PROPRIETARY NAME: | Helios Laser Imager 1417 |
| ESTABLISHMENT No. | 1043882 |
| PERFORMANCE STANDARDS: | The device complies with the relevant international |
and national Safety Standards. It has been manufactured in compliance with ISO9000 and the Quality System Regulation [21 CFR 820].
## SYSTEM DESCRIPTION:
The device accepts electrical image signals and produces hard copy images. The image signal source may be digital formatted image data from image readers or unformatted image data from other imaging modalities (e.g. CT, MRI). The image signal source may be analog or digital. The Helios Laser Imager uses the information in the image signals digitally record diagnostic images and patient data on a proprietary product specific medical imaging media. The Helios does not use conventional light-sensitive silver halide photographic media, requires no dark room, film processor, processing chemicals, water, drainage, or dryer ventilation. It produces no chemical waste, and requires no space for chemical storage.
More detailed information regarding the Helios can be found in the preliminary System Specification included in Section 2 as well as Section 4.
#### EQUIVALENCE INFORMATION:
This submission is for a modification of the previously cleared Helios Laser printer (K912073).
> Sterling Diagnostic Imaging, Inc. 10 South Academy Street Mailbox 120 P.O. Box 19048 Greenville, SC 29602-9048
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August 11, 1997 Page - 2
> There are two primary differences between the new version of the Helios, referred to as "C" during development, and its predecessor. First is the increased number of lasers to allow the simultaneous printing of 2 lines of image data; thus increasing the throughput. Secondly, the DICOM print server previously located external to the device has now been incorporated into the system.
> to the aforementioned modifications, two non-significant addition In madifications are being incorporated into the "C" design. The mechanical sheet feeder has been improved for increased cost efficiency and reliability. The electronics modules have also been consolidated.
> These modifications do not change the technology or safety of the Helios printer. The intended use and indications also remain unchanged. The Helios "C" is without question substantially equivalent to its predecessor and is safe and effective ffor its intended use.
#### SAFETY INFORMATION:
The results of the hazard analysis, combined with the appropriate preventive measures taken indicate the device is of minor level of concern, as per the August 29, 1991 issue of the "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by additional trained professionals allowing sufficient review to afford identification and intervention in the event of a malfunction. The device does not impact the quality or status of the original acquired image data.
Sterling Diagnostic Imaging feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence within a reasonable time period. In the event that additional information is required, please contact the undersigned or Ms. Debra Hutson.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HU" are arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Timothy W. Capehart Manager of Regulatory Affairs and Compliance Sterling Diagnostic Imaging, Inc. 10 South Academy Street Mailbox 120 P.O. Box 19048 Greenville, SC 29602-9048
Re: K973028 Helios Laser Imager 1417 Dated: August 11, 1997 Received: August 14, 1997 Unclassified Procode: 90 LMC
OCT 2 8 1997
Dear Mr. Capehart:
We have reviewed your Section 510(k) notification of intent to market the device 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 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 probibitions against misbranding and adulteration.
If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 begine your device as described in your 5100k) 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
Enclosure
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K973028 510(k) Number (if known) :
Device Name :
Helios Laser Imager
Indications for Use:
The Raven is a free standing device used to print diagnostic images for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel li. Sypon
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Deyi 510(k) Number
3
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use ___________
