(77 days)
Not Found
No
The summary describes a medical imager and video capture system for converting electronic signals to hard copy, with no mention of AI or ML capabilities.
No
The device is described as a medical imager and video capture system used for converting electronic signals from medical imaging modalities into hard copies. Its function is for printing images for diagnosis and record keeping, not for treating a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" states that the hard copies produced are "suitable for diagnosis and record keeping." This directly indicates that the device's output is intended to be used in the diagnostic process.
No
The device description explicitly mentions "medical imager & Video Capture Box systems" and "printing color or monochrome images on paper and or film media," indicating hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert electronic signals from medical imaging modalities into hard copy for diagnosis and record keeping. This is a function related to medical imaging, not the analysis of biological samples (like blood, urine, tissue, etc.) which is the core of IVD devices.
- Device Description: The description focuses on printing images on paper or film media, again aligning with medical imaging output, not laboratory analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, the Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems fall under the category of medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
Product codes
LMC
Device Description
The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical imaging modalities
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2040 Medical image hardcopy device.
(a)
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.(b)
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.
0
JUN 30 1999
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section
510(k) Summary of Safety and Effectiveness
for Seiko Instruments, ColorPoint™ 1700 Medical Imagers and Video Capture Box (VCX) systems
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
April 7, 1999
Submitter's Information:
Seiko Instruments Inc. Print System Division 8. Nakase 1-chome Mihama-ku Chiba-shi Chiba 261-8507 Japan
Trade Name, Common Name, Classification:
Seiko Instruments, ColorPoint™ 1720 Medical Imagers and Trade Name: Video Capture Box CX-1000 series Common Name: Medical Imager & Video Capture Device Classification Camera, Multiformat Name:
Predicate Device:
| Manufacturer: | Seiko Instruments Inc. |
|---|---|
| Device: | ColorPoint™ Model 820 Medical Image |
| 510(k) Number: | K971760 |
| Date Received: | 05/12/97 |
| Decision Date: | 10/01/97 |
| Decision: | Substantially Equivalent |
| Panel Code device reviewed by: Radiology | |
| Panel Code device classified by: Radiology | |
| Product Code: | LMC |
| Classification: | Class II |
Device Description:
The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.
1
Indications for Use:
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
Technological Characteristics:
The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being printed.
Conclusion:
The 510(k) Pre-Market Notification for the above referenced device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to Seiko Instruments Inc. ColorPoint™ Model 820 Medical Imager K971760.
- The ColorPoint™ system has been and will be manufactured in accordance 1. with the voluntary standards listed in the enclosed voluntary standard survey.
-
- The submission contains the results of a hazard analysis. All potential hazards have been classified as MINOR.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The symbol in the center appears to be an abstract representation of an eagle or bird with three curved lines forming its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1999
Seiko Instruments USA., Inc. c/o Herman Oosterwjick Division of Otech, Inc. 2001 East Oakshores Drive Crossroads. TX 76227
RE:
Trade Name: Colorpoint 1720 Medical Imagers and Video Capture Box CX-1000 Series Date: March 31, 1999 Received: April 14, 1999 Classification: II 21 CFR 892.2040 Product Code: 90 LMC
Dear Mr. Oosterwjick:
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 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). You may, therefore, market the device, subject to the general controis provisions of the Act. The general controls provisions of the Actively 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 dass III (Special Controls) or dass 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 requirements, 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 Eederal 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 the Electronic Product 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
(Indications for Use Form)
K991282 510(k) Number:
Device Name:
Seiko Instruments, ColorPoint™ 1720 Medical Imagers and Video Capture Box CX-1000 series
Indications for Use:
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Vomit h. Segum
(Optional Format 1-2-96)
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, Division of Radiological Devic 510(k) Number
510(k) for Seiko Instruments, ColorPoint™ 1720 Medical Imagers and Video Capture Box CX-1000 Page 13