(90 days)
C150XP's Physician Workstation, NetraMD Workstation, AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation, VRSAPP Workstation
Not Found
No
The document describes advanced post-processing of CT data and image manipulation, but there is no mention of AI, ML, or related terms. The focus is on standard image processing and viewing functionalities.
No
The device is described as an accessory to a CT scanner, intended for post-processing CT data to aid in diagnosis, not for providing therapy.
Yes
The device description explicitly states that the workstation is intended "as an aid in diagnosis."
No
The description refers to a "Workstation," which typically implies a physical computer system with hardware components, not solely software. While it processes data, the context suggests it's a dedicated hardware/software system.
Based on the provided information, the Imatron Ultra Access Workstation is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Imatron Ultra Access Workstation processes and manipulates imaging data from a CT scanner. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis". This is related to medical imaging, not in vitro testing.
Therefore, the device falls under the category of medical imaging software or a medical image processing workstation, not an IVD.
N/A
Intended Use / Indications for Use
The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data.
Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.
Product codes
90 JAK
Device Description
The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data.
Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as the predicate devices - for receiving, viewing, manipulating, transmitting, storing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis. by a trained physician.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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 Ultra Access Workstation successfully passed all testing at Imatron. Such testing indicates that the device as described in this submission is substantially equivalent to predicated devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the C150XP's Physician Workstation, the NetraMD Workstation, the AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation, the VRSAPP Workstation
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a stylized, bold, and black text. The text appears to be a brand name or a title, with a unique design that incorporates horizontal lines within each letter. The font is sans-serif and the letters are closely spaced, creating a compact and impactful visual. The overall impression is modern and attention-grabbing.
K97 29 03
NOV - 4 1997
510(K) SUMMARY
Submitter's Name:
Imatron, Inc.
Address:
Phone(s):
Contact Person:
Date:
Common Names:
Proprietary Names:
Classification Name:
389 Oyster Point Blvd. South San Francisco, CA 94087
(0) 415-583-9964, ext. 206 (F) 415-827-7790
J.A. Coduto
August 8, 1997
Workstation, Image Processing Workstation, and Image Workstation
Imatron Ultra Access® Workstation with Cardiac Software Extensions
No classifications have been specifically issued No classifications have been benefits. For purposes of lor PACS of TROO ecall equivalence workstations determining substantial oquired to medical imaging devices.
The Imatron Ultrafast CT scanner is such an The "Imatron" Onraido. "Onraido. "Such, is Class II (reference: Imaging device and, as section sales Ultra Access Workstation is similarly classified.
1
Predicate Device:
Device Description:
Predicate devices include: the C150XP's Physician Workstation as a component of the Imatron scanner (an Imatron, Inc. product); the NetraMD Workstation (a Scimage, Inc. product); the AIDP (Acculmage, Inc. Image Display Processor) Imatron/DICOM Image Processing Workstation (an Acculmage, Inc. product); and the VRSAPP Workstation (an ISG Technologies product).
Device Description
The Imatron Ultrafast CT Scanner --
The Imatron Ultrafast CT scanner is a scanning system (like those generically described in 21 CFR section 892.1750, which deals with "computed tomography X-ray systems") which operates by directing a focused beam of electrons along tungsten target rings to produce X-rays which pass through the body at multiple angles as in conventional CT scanning systems.
The Imatron Ultrafast CT scanner is capable of producing CT slices at rapid speeds since the data is produced by electronic rotation of the electron beam itself rather than the mechanical rotation of an X-ray tube as in conventional CT scanning systems.
the Imatron Ultrafast CT scanner Currently. operating at its highest resolution mode has 864 single or paired, contiguous X-ray detectors subtending an arc of 0.250 degrees each. The resulting 5% amplitude modulation transfer function (MTF) for high contrast objects at the center of the circle of reconstruction is 7 line pairs per centimeter (lp/cm).
Such scanner has the current ability to receive. manipulate, transmit, store, view, characterize, compare and enhance medical images.
The ISG Workstation --
The ISG Workstation is a device for picture
2
archiving and communications cleared for use in processing and displaying medical images on a monitor, storing medical image data on fast access media, i.e. hard disk, and on slow access media, i.e. archive media, and transmitting data over local and wide area networks.
The Significant Modification
The only change Imatron is making to ISG's Workstation is the addition of a software package. This package is in addition to (not an amendment of) the software package currently provided with the ISG Workstation. Such package is described in detail within this 510(k) submission, as is the Workstation's intended use.
The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data.
Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as the predicate devices - for receiving, are viewing, manipulating, transmitting, storing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis. by a trained physician.
See attached Substantial Equivalence Comparison and Explanation of Differences
Although there are no performance standards established by FDA for PACS devices, the Ultra Access Workstation has been designed and manufactured to meet: the ACR/NEMA Digital Imaging and Communications in Medicine (DICOM) Standard, version 3.0; and the ACR/NEMA DICOM 3.0 Digital Interchange Standard for Cardiology (DISC95-96). The device and its development
Intended Use:
Technological Characteristics:
Performance:
/
3
process also comply with FDA's, August 29, 1991 guidance document titled: "Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review".
Testing Conclusions:
The Ultra Access Workstation successfully passed all testing at Imatron. Such testing indicates that the device as described in this submission is substantially equivalent to predicated devices.
4
SUBSTANTIAL EQUIVALENCE COMPARISON TABLE
ﺴﻴﺴﻪ:
Following in tabular (Table 2) and explanation form is a comparison of the similarities and differences that exist betweer the subject device and the predicate devices.
| TABLE 2: COMPARISON OF FEATURES AND SPECIFICATIONS | ||
|---|---|---|
| ---------------------------------------------------- | -- | -- |
| ITEM | FEATURE | ULTRA ACCESS
DEVICE | C150 XP
DEVICE | NETRA MD
DEVICE | AIDP
DEVICE | VRSAPP
DEVICE |
|------|------------------------------------|------------------------|-------------------|--------------------|----------------|------------------|
| 1 | 2D image review | Yes | Yes | Yes | Yes | Yes |
| | Multiplanar reformatting | Yes | Yes | Yes | Yes | Yes |
| | 3D surface and volume
rendering | Yes | No | Yes | Yes | Yes |
5
| ITEM | FEATURE | ULTRA ACCESS
DEVICE | C150 XP
DEVICE | NETRA MD
DEVICE | AIDP
DEVICE | VRSAPP
DEVICE |
|------|-----------------------------------------------------|------------------------|-------------------|--------------------|----------------|------------------|
| | Maximum intensity
projection | Yes | No | Yes | Yes | Yes |
| | Performance of CTA and
MRA | Yes | No | Yes | Yes | Yes |
| | Image archiving | Yes | Yes | Yes | Yes | Yes |
| | Image filming | Yes | Yes | Yes | Yes | Yes |
| | Image transfer or network
connectivity | Yes | Yes | Yes | Yes | Yes |
| 2 | Examination of 2D image
data from a calcium scan | Yes | Yes | Yes | Yes | Yes |
| 3 | Examination of calcium
scan as a 3D volume | Yes | No | Yes | Yes | No |
)
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| ITEM | FEATURE | ULTRA ACCESS
DEVICE | C150 XP
DEVICE | NETRA MD
DEVICE | AIDP
DEVICE | VRSAPP
DEVICE |
|------|-------------------------------------------------------------------------------|------------------------|-------------------|--------------------|----------------|------------------|
| 4 | Semi automated
identification of regions
that are considered
calcium | Yes | No | Yes | Yes | No |
| 5 | User override of
automatically identified
regions | Yes | No | Yes | No | No |
| 6 | Automatic computation of
calcium score | Yes | No | Yes | No | No |
| 7 | Ability to measure CT
numbers on a 2D image | Yes | Yes | Yes | Yes | Yes |
| 8 | Identification of
mistriggered slices | Yes | Yes | No | No | No |
| 9 | Saving of calcium data with
patient exam data | Yes | Yes | Yes | No | No |
| ITEM | FEATURE | ULTRA ACCESS
DEVICE | C150 XP
DEVICE | NETRA MD
DEVICE | AIDP
DEVICE | VRSAPP
DEVICE |
| 10 | Creation of a paper
calcium report | Yes | No | Yes | No | No |
| 11 | Comparison of multiple
scans | Yes | No | Yes | No | No |
| 12 | Identification of
mistriggered TDA data | Yes | Yes | No | No | No |
| 13 | Deselection of a
mistriggered image | Yes | Yes | No | No | No |
| 14 | Identification of regions for
which TDA computation
should be performed | Yes | Yes | No | No | No |
| 15 | Automatic creation of
gamma-variate curve fit for
TDA data | Yes | Yes | No | No | No |
| 16 | Computation of curve
parameter | Yes | Yes | No | No | No |
| 17 | Computation of perfusion | Yes | Yes | No | No | No |
| ITEM | FEATURE | ULTRA ACCESS
DEVICE | C150 XP
DEVICE | NETRA MD
DEVICE | AIDP
DEVICE | VRSAPP
DEVICE |
| 18 | Creation of a parametric
image | Yes | Yes | No | No | No |
| 19 | Creation of a paper TDA
report | Yes | No | Yes | Yes | No |
| 20 | Indications for use-
general medical imaging
workstation | Yes | Yes | Yes | Yes | Yes |
| 21 | Indication for use --
calcium | Yes | Yes | Yes | Yes | No |
| 22 | Indication for use -- TDA | Yes | Yes | No | No | No |
)
ﺮ ﺮ
7
مب
8
9
ITEM 3: REFORMATTING VS. SHADED SURFACE DISPLAY. Reformatting and shaded surface display are both well accepted methods of examining volumetric data. Gray scale information is lost in a shaded surface display, but because we are looking at high-contrast areas (calcium vs. surrounding tissue), gray scale information is not required. This difference does not affect safety or efficacy.
ITEM 4: FOOTPRINT IDENTIFICATION VS. COLORED SHADED SURFACE. Large contrast difference exist between calcified regions and soft tissue. Therefore, these regions can be identified equally readily on a maximum intensity projection (footprint method) or in a shaded surface display. We have chosen to use a 3D display because the spatial relationships between calcified regions are more clearly observable in a 3D display, and thus calcified regions in arteries and in non-arteries can be more clearly identified. This difference does not affect safety or efficacy.
ITEM 9: SAVING OF 3D DESCRIPTIONS VS. ROIS. The location of calcified regions can be stored as a set of (x, y, z) coordinates or as a set of (x, y, slice position) coordinates. In an axial scanning modality like CT, slice position and the z coordinate are proportional, and thus this difference does not affect safety or efficacy.
ITEM 10: VIEWING OF REPORT DATA IN MICROSOFT WORD OR IN NETSCAPE. Both methods allow a user to view text and image data, and to print these data onto paper. This difference does not affect safety or efficacy.
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ITEM 11: VIEWING OF DUAL-SCANS ON SAME SHEET OR ON TWO-DIFFERENT SHEETS. Both methods allow for side-by-side comparison of two calcium scans. No functional difference is obtained by using two sheets of paper or one. This difference does not affect safety or efficacy.
ITEM13: USE/NO-USE VS. CLICKING ON AN IMAGE TO INDICATE DESELECTION. Both methods allow the user to tell the software which images to ignore when performing the subsequent gamma-variate curve fit. Ultra Access uses a more graphical approach (clicking on the image) to make it easier for the user to determine which slices were deselected and which were not. This difference does not affect safety or efficacy.
ITEM 17: SUPPORT OF 1 PERFUSION ALGORITHM OR 4. Ultra Access supports the perfusion algorithm used in the predicate device's software. However, as shown by the attached scientific references, other newer algorithms may vield more accurate results at higher flow states. Therefore, these additional algorithms have been provided. This difference does not affect safety or efficacy.
ITEM 18: GRAYSCALE VS. COLOR PARAMETRIC IMAGES. Both systems support grayscale mappings of curve parameter values. However, as the human eye can better perceive subtle changes in color than it can subtle changes in gray values, we have also provided color mappings. This approach is identical to that used in Nuclear Medicine or in PET scanning. We also support the colored display of perfusion. This parameter is being computed by the predicate device, but only being displayed as a number (as opposed to a colored map). Ease of use will be enhanced by displaying this additional parameter in color. This difference does not affect safety or efficacy.
ITEM 20: PAPER PRINTOUT MAP OF TDA REPORT. The predicate device creates paper reports describing the results of a calcium scan. In addition to supporting this type of printout in Ultra Access (see Item #10), Ultra Access will also create paper reports of TDA data. The data being placed on paper is identical to the data being computed by the C150XP predicate device, and therefore placing this information on paper (using a color ink) et printer to preserve color information) does not change its clinical meaning. This difference does not affect safety or efficacy.
11
Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HU" are arranged in a semi-circle around the left side of the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 4 1997
J. A. Coduto Director, Regulatory Affairs Imatron, Inc. 389 Oyster Point Blvd. South San Francisco, CA 94080 Re: K972903 Imatron Ultra Access Workstation with Cardiac Software Extensions Dated: August 8, 1997 Received: August 6, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK
Dear Mr. Coduto:
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 misbranding and adulteration.
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 Ouality 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 begin marketing 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 question 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/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
12
SECTION 3: PROPOSED INTENDED USE STATEMENT
The Imatron Ultra Access Workstation is intended as an accessory to Imatron's Ultrafast Computed Tomography (CT) Scanner, a cleared device. The Ultra Access Workstation accepts data from Imatron's Ultrafast CT scanner and allows for advanced post processing of such data.
Thus, as modified from the ISG Workstation, the Imatron Ultra Access Workstation is intended - as are the predicate devices - for receiving, manipulating, transmitting, storing, viewing, characterizing, comparing and enhancing high quality CT electronic images, as an aid in diagnosis, including for cardiac analysis, by a trained physician.
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT Division of Reproductive, .
and Radiological Devices
Bro 510(k) Number
Prescription Use
(Per 21 CFR 801.109)