(70 days)
90LMA
Not Found
No
The description details a standard film digitizer using CCD technology and SCSI connection, with no mention of AI or ML algorithms for image processing or analysis.
No
The device digitizes medical radiographs for PACS and teleradiology, which are systems for image management and transmission, not active diagnosis or treatment.
No
The device digitizes radiographs for PACS and teleradiology without analyzing or interpreting the medical image information for clinical decision-making.
No
The device description clearly states it is a "transparency, charge coupled device (CCD) scanner" and describes physical components like a "film fed drive," "camera," "charge coupled device (CCD)," and an "OCP board" for analog to digital conversion. This indicates it is a hardware device with associated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate digital signals from medical radiographs for use in PACS and teleradiology. This is related to medical imaging and data management, not the examination of specimens derived from the human body.
- Device Description: The device is a film digitizer that converts physical radiographs into digital images. It processes existing images, not biological samples.
- Lack of IVD Characteristics: The description does not mention any interaction with biological specimens, reagents, or diagnostic tests performed on samples from the human body.
IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that scope.
N/A
Intended Use / Indications for Use
The 960 reads gray information from the image and sends the raw digital data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the marketplace as a separately approved third-party software package. The re-user is responsible for detailing the Indications For Use for the PAC System (or teleradiology software package) as a whole, including the 960.
The device is used in generating digital signals from medical radiographs. The digital signals are intended for use in PACS and tele-radiology.
Product codes
90LMA
Device Description
The device is a transparency, charge coupled device (CCD) scanner which can be used to digitize radiographs or X-ray film. The digitizer reads gray digital information from the image and sends the raw data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the market place as separately approved third party software packages or complete PAC system. The user interface for the film digitizer resides in the host application software program.
The 960 creates a digital image file from transparent originals. The digital image file is expressed in either 8 or 12 bit grav level file format. The digitizer is connected to a host computer (either PC, Mac or UNIX) via SCSI II. There is no "activate" button the 960. To start an image capture operation, the user must activate the digitizer user interface on the host computer.
Overall, The 960 uses a film fed drive which transports the film over the camera as it digitizes the image. Each scan line is captured by the charge coupled device (CCD). The scan line of data is normalized and calibrated to align the response from individual CCD receptors. The image data signal is converted from analog to digital format on the OCP board. The digital signal is then sent to the host via the SCSI II connection with the host computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The performance testing results for the 960 Film Digitizer demonstrated that the device meets its intended specifications and therefore, meets the requirements necessary for its intended use as a component of a PAC system or teleradiology software package.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Howtek Scanmaster DX Film Digitizer
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
Section VII
FOI 510(k) Summary
20 1997
In conformance with Section 513(l)(3) of the Food, Drug, and Cosmetic Act, Howtek Incorporated hereby submits with this Premarket Notification an adequate summary of any information on safety and effectiveness.
| Submission Date: | March 5, 1997 | |
|---|---|---|
| Owner / Operator: | Howtek Incorporated | |
| 21 Park Avenue | ||
| Hudson, New Hampshire 03051 | ||
| Device Common / Usual Name: | Film Digitizer | |
| Device Trade Name: | Howtek 960 | |
| Classification Name: | Digitizer, Film (90LMA) | |
| Class II | ||
| Teleradiology Device | ||
| PAC Peripheral Device | ||
| Predicate or Legally | ||
| Marketed Devices: | Howtek Scanmaster DX | |
| Film Digitizer |
Description of Device:
The device is a transparency, charge coupled device (CCD) scanner which can be used to digitize radiographs or X-ray film. The digitizer reads gray digital information from the image and sends the raw data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the market place as separately approved third party software packages or complete PAC system. The user interface for the film digitizer resides in the host application software program.
The 960 creates a digital image file from transparent originals. The digital image file is expressed in either 8 or 12 bit grav level file format. The digitizer is connected to a host computer (either PC, Mac or UNIX) via SCSI II. There is no "activate" button the 960. To start an image capture operation, the user must activate the digitizer user interface on the host computer.
Overall, The 960 uses a film fed drive which transports the film over the camera as it digitizes the image. Each scan line is captured by the charge coupled device (CCD). The scan line of data is normalized and calibrated to align the response from individual CCD receptors. The image data signal is converted from analog to digital format on the OCP board. The digital signal is then sent to the host via the SCSI II connection with the host computer.
1
Indications For Use:
The 960 reads gray information from the image and sends the raw digital data file to a host computer, for use with a Picture Archiving and Communication (PAC) System or teleradiology software package currently in the marketplace as a separately approved third-party software package. The re-user is responsible for detailing the Indications For Use for the PAC System (or teleradiology software package) as a whole, including the 960.
Contraindications
The 960 will be marketed as a component to the software development companies, who will incorporate the 960 into their respective PAC System or teleradiology software package. The software developer will be responsible for detailing the Contraindications for the PAC System (or teleradiology software package) as a whole, including the 960.
Potential Complications
The 960 will be marketed as a component to the software development companies, who will incorporate the 960 into their respective PAC System or teleradiology software package. The software developer will be responsible for detailing the Potential Complications for the PAC System (or teleradiology software package) as a whole, including the 960.
Technological Characteristics of Proposed and Predicate Devices
The proposed 960 has the same basic characteristics as the predicate Howtek Scanmaster DX. The DX is designed to digitize X-ray film or radiographs. In addition, the predicate scanner operates at lower scan rates, less density range, less gray scale resolution and less spatial resolving power. The 960 is superior to all of the listed predicate devices.
Performance Characteristics
The performance testing results for the 960 Film Digitizer demonstrated that the device meets its intended specifications and therefore, meets the requirements necessary for its intended use as a component of a PAC system or teleradiology software package.
2
Section VII
Conclusion
Based on the information presented in this Premarket Notification, Howtek, Incorporated believes that the proposed 960 Film Digitizer is substantially equivalent to the Scanmaster DX Film Digitizer. The 960 is equivalent to the predicate film digitizer in regard to its intended use ( i.e. it captures X-ray films or radiographs as part of a PAC System or teleradiology software package). The technological characteristics are substantially equivalent in that they are both CCD based film digitizers. The performance characteristics show that the 960 has better range and better resolution that the predicate device, therefore, is more than capable of providing equivalent performance to the DX.
3
Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH, HUMAN SERVICES, USA" around the edge. Inside the circle is a stylized image of three overlapping human profiles. The profiles are facing to the right and are connected by a wavy line at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
M. Russell Leonard Chief Operation Officer Howtek, Inc. 21 Park Ave. Hudson, NH 03051
ിറ്റ്റ് 2 ปี MAY
Re: K970908 Howtek 960 Dated: March 5, 1997 Received: March 11, 1997 Regulatory class: Unclassified Procode: 90 LMA
Dear Mr. Leonard:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have decemined 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 Amendances, 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 misbrancing and adulteration.
If your device is classified (see above) into either class II (Prematket 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. This response to your premarket notification does not affect any obligation you might have under sections 51 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 predication or 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) 594-4591 for Radiology devices or 594-4613 for Ear, Nose and Throat devices. Additionally, for questions on the promotion and advertising of your device, please of the Office of Compliance at (301) 594-4639. Also, please noted, "Misbnading 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 vours
Miany
Lillian Yin, PlLD. 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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510(k) Number ( if Known ): __________________________________________________________________________________________________________________________________________________
Howtek 960 Film Digitizer_____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
rr
The device is used in generating digital signals from medical radiographs. The digital signals are intended for use in PACS and tele-radiology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel le. deymm
(Division Sign-Off)
Division of Reproductive, Abdominal, EN and Radiological Device
510(k) Number K970908
Prescription Use:_____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use: ________________________________________________________________________________________________________________________________________________________