(83 days)
Not Found
No
The description focuses on standard image processing techniques (filtering, windowing, zoom/roam, subtraction) and multimodality viewing, which are common in medical imaging workstations and do not inherently indicate AI/ML. There is no mention of AI, ML, deep learning, or any related concepts.
No
The device is used to assist physicians in diagnosis and treatment planning by reviewing and processing angiographic images, but it does not directly treat a disease or condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the images processed by the device are "intended to assist the physician in diagnosis and treatment planning." This directly indicates a diagnostic purpose.
Unknown
The provided text describes software functionalities for image processing and viewing, but it does not explicitly state that the device is only software. The absence of a "Device Description" section makes it impossible to confirm if there are any associated hardware components included in the submission.
Based on the provided information, this device 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 intended use and device description clearly state that this device processes and reviews images acquired from medical imaging modalities (angiography, CT, MRI). It does not perform tests on biological samples.
- Intended Use: The intended use is to assist physicians in diagnosis and treatment planning by providing tools to review and process medical images.
Therefore, this device falls under the category of medical imaging software or a medical image processing workstation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended for use to independently review and process anglographic images outside the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
Product codes
90 LLZ
Device Description
Not Found
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Angiographic x-ray, computer tomographs, magnetic resonance scanners
Anatomical Site
vessel malformations
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / outside the exam room
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(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).
0
SEP 9 1999
Summary Of Safety and Effectiveness
l. General Information Classification Name: Classification Number: Class of Device: Common/Usual Name: Device Trade Name:
Angiographic x-ray system 21 CFR 892.1600 = review workstation AX Workstation
Siemens Medical Systems, Inc.
Intended Use: Intended for use to independently review and process anglographic images outside the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
Establishment Name and Address:
| Nuclear Medicine Group | |
|---|---|
| 2501 North Barrington Road | |
| Hoffman Estates, IL 60195-5203 | |
| Establishment Registration | |
| Number: | 1423253 (Owner/Operator 9010023) |
| Performance Standard: | None established under Section 514 of The |
Il Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.
Substantial Equivalence:
The AX Workstation is substantially equivalent to currently marketed Siemens Medical Systems. Inc. TOP ACOM Station (K945293) with accessory ACOM.PC+ and Camtronics Analytical Review Station (K955519).
Contact:
Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203 Phone: (847) 304-7516 Fax: (847) 304-6023 E-Mail: robert.callahan@nmg.sms.siemens.com
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
SEP . g 1999
Mr. Robert W. Callahan Manager of Regulatory Affairs Siemens Medical Systems, Inc. 2501 North Barrington Road Hoffman Estates, IL 60195-5203
Dear Mr. Callahan:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K992073 Re: AX Workstation Dated: June 17, 1999 Received: June 18, 1999 Regulatory Class: II (two) Product Code: 90 LLZ 21 CFR 892.2050
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 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 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 requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther 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.qov/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
2
Indications for Use Form
510(k) Number (if known)_K 9920Z3
Device Name: AX Workstation
Indication for Use:
AX Workstation will be used to independently review and process angiographic images outside of the exam room. These images are intended to assist the physician in diagnosis and treatment planning of vessel malformations and other diseases or injuries for which digital x-ray imaging is a suitable means for visualization. Image processing functions similar to currently commercially available Siemens digital angiography systems including filtering, gray scale windowing, zoom/roam, and subtraction will be provided to support diagnosis and treatment planning as well as quantification, report and archival functions. A multimodality viewer allows viewing of images previously acquired on computer tomographs and magnetic resonance scanners, providing viewing of different imaging modalities for the same patient on the same workstation to further support diagnosis and treatment planning.
PLEASE DO NOT WRITE BELOW THIS LINE Concurrence of the CDRH, Office of Device Evaluation (O,DE)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number
Prescription Use (Per 21 CFR 801.109)
Or
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________