(59 days)
Not Found
No
The document describes a film digitizer and does not mention AI, ML, or any related concepts in its description, intended use, or performance studies.
No
The device converts radiographic films into a digital format for managing images; it does not provide therapy or treatment for any medical condition.
No
The device converts existing radiographic films into a digital format (DICOM) for archival or viewing purposes. It does not analyze or interpret the images to provide diagnostic information about a patient's condition.
No
The device description explicitly states it is a "system to convert radiographic films into a digitized format," implying the use of hardware (a digitizer) to perform the conversion, not just software processing of existing digital data.
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 radiographic films into a digital format (DICOM) for use in an image management system. This is a process of digitizing existing medical images, not performing a diagnostic test on a biological sample.
- Device Description: The description reinforces the function of converting films to digital images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely related to image handling and conversion.
N/A
Intended Use / Indications for Use
The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.
Product codes (comma separated list FDA assigned to the subject device)
90 LMA
Device Description
The Imation™ Trimatic Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.
The Imation™ Trimatic™ Film Digitizer uses a laser scanner to scan and digitize the film image. The digital image has 12 bit image depth and is in Dicom 3.0 format. The scan rate and spot size are adjusted depending on the film type to accurately capture either 5 or 10 line pairs per mm for standard and mammographic films, respectively.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic films (standard and mammographic x-rays)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital or other clinical Image Management System(IMS)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 25 1999
Image /page/0/Picture/1 description: The image shows the logo for Imation, a company that was spun off from 3M. The logo features a hand holding a wand, with a trail of plus signs and dots emanating from the wand. The text "IMATION" is written in a bold, sans-serif font below the wand and hand. The phrase "Borne of 3M Innovation" is written in a smaller font below the company name.
Imation Corp. 1 Imation Place Oakdale, MN 55128-3414 612 704 4000 phone 800 537 4675 fax
510(k) Summary
Nov 25, 1998
Imation Corp. 1 Imation Place Oakdale MN 55128-3414 Contact: Stephen G. Slavens 1 Imation Way DIS-4B-75 Oakdale MN 55144-3414 Phone: 651-704-3536 FAX: 651-704-4469
| Device: | Trade name: | Imation™ Trimatic™ Digital System |
|---|---|---|
| Common name: | PACS System | |
| Classification name: | Image Processing System LLZ | |
| 21 CFR 892.2020 Class II |
Predicate device:
The Imation™ Trimatic Digital System is comprised of cleared or exempt devices with the exception of the digitizer, which is identical to the digitizer in clearance (K982785) except for minor film feeding hardware and communication software.
Description and Intended Use of Device:
The Imation™ Trimatic™ Digital System is intended for use as a system to convert radiographic films into a digitized format for use in a hospital or other clinical image management system. The digitized image receives patient and exam information and is then forwarded into a DICOM compliant image management system. The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-rays.
Technological Characteristics:
The Imation™ Trimatic™ Film Digitizer uses a laser scanner to scan and digitize the film image. The digital image has 12 bit image depth and is in Dicom 3.0 format. The scan rate and spot size are adjusted depending on the film type to accurately capture either 5 or 10 line pairs per mm for standard and mammographic films, respectively.
1
Performance Data:
| Voluntary standards used in the design of the subject device(s) are: | ||
|---|---|---|
| UL1950 | Safety of Information Technology Equipment | |
| 21 CFR1040 | Laser Safety Standards | |
| IEC825 | Laser Safety Standards | |
| EN60601-1-2 Class A | Electro-Magnetic Compatibility | |
| EN55011 | 1991-97 | Radiated and Conducted Immunity |
| EN55014-1 | 1993-97 | Conducted Immunity |
| EN61000-4-2 | 1995 | Electro-Static Discharge |
| EN61000-4-3 | 1996 | Radiated Radio-frequency |
| ENV 50204 | 1995 | Immunity to RF Telephone Emissions |
| EN61000-4-4 | 1995 | Electronic Fast Transfer |
| EN61000-4-5 | 1995 | Surge |
| EN61000-4-6 | 1996 | Conducted immunity |
| EN61000-4-8 | 1993 | Power Frequency Magnetic Field |
| EN61000-4-11 | 1994 | Power Line Fluctuation |
Conclusion:
The Imation™ Trimatic™ Digital Imaging System has no patient contact, does not control or monitor patient medical status. Digital images generated by the Trimatic Digital System are interpreted by competent medical practitioners, offering ample opportunity for competent human intervention where warranted.
Imation believes the subject device is safe and effective based on comparison to the predicate device, on prior clearance of devices incorporated in this system and by conformance to the above design standards.
2
- 2017-02-04 11:12:13
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 25 1999
Stephen G. Slavens Regulatory Affairs Manager Imation Corp. 1 Imation Place Oakdale, MN 55128-3414
Re: K984252
Imation™ Trimatic™ Digital System Dated: November 25, 1998 Received: November 27, 1998 Regualtory class: II 21 CFR 892.2030/Procode: 90 LMA
Dear Mr. Slavens:
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 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 misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or 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 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 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation 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
ATTACHMENT 2
Statement of Indications for Use:
| 510(K) Number (if known): | K984252 |
|---|---|
| --------------------------- | --------- |
Device Name: Imation™ Trimatic™ Digital System
Indications for Use:
The Imation™ Trimatic™ Digital System is intended for use an automated system to convert radiographic films into a DICOM format image for use in a hospital or other clinical Image Management System(IMS). The digitizer has the resolution capable of faithfully digitizing standard and mammographic x-ray films.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_X (Per 21 CFR 801.109) OR
Over-the- Counter Use_
David C. Seaman
(Division Sign-Off) ovision of Reproductive, Abdominal, El ud Radiological Vk) Number