(85 days)
Not Found
No
The description focuses on image reconstruction and standard post-processing/measurement tools, with no mention of AI/ML terms or capabilities.
No
The device is described as software that assists physicians in diagnosis by visualizing and measuring composite images, rather than directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the software is "intended to assist the physician in diagnosis and treatment."
Yes
The device is described as a "Software Option" and its function is to process and display images generated by external hardware (x-ray systems). There is no mention of the device including or requiring any specific hardware components beyond the workstation it runs on.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device function: The AX Workstation DR-Viewer Software Option processes and visualizes medical images generated by X-ray systems. It works with images of internal anatomy (spine, legs, colon) obtained directly from the patient, not from specimens taken from the patient.
- Intended Use: The intended use is to assist physicians in the diagnosis and treatment of musculoskeletal and gastrointestinal conditions based on these images.
The device falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The AX Workstation DR-Viewer Software Option offers the user the ability to visualize composite images of selected anatomy (i.e. spine, legs, colon). The images produced by the package, as well as the measurement tools of DR-Viewer, are intended to assist the physician in diagnosis and treatment of musculoskeletal disorders and conditions of the gastrointestinal tract.
Product codes
LLZ
Device Description
The AX Workstation DR-Viewer Software Option uses a series of images of the anatomy (i.e. spine, legs, colon) generated with a radiographic, fluoroscopic, or angiographic x-ray system, and reconstructs the images into a single composite image format. After reconstruction of the image, the software provides the user with various measurement tools and post-processing functions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic, fluoroscopic, or angiographic x-ray system
Anatomical Site
spine, legs, colon (musculoskeletal and gastrointestinal tract)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
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
§ 892.2050 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
. .!.
ુંત્
પુરત
ર I
i i
Image /page/0/Picture/1 description: The image shows the word "SIEMENS" in large, bold, black letters. Below the word "SIEMENS", there is a date, August 27, 1999. The text is centered in the image. The font is sans-serif.
August 27, 1999
Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Control Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850
Subject: 510(k) Submission for the Siemens AX Workstation DR-Viewer Option
Dear Document Control Clerk:
In accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act, Siemens Medical Systems, Inc. is submitting, in duplicate, a Premarket Notification [510(k)] for the DR-Viewer Software Option, for use in viewing angiographic image data. The following information is provided in accordance with 21 CFR § 807.87 and the guidance document "Addendum: How to Submit a Premarket Notification [510(k)] March 1995" from the Center for Devices and Radiological Health.
Reason for Submission: 1.
Siemens Medical Systems, Inc. intends to market, the DR-Viewer Software Option which is loaded and executed on the AX Workstation (K991972, currently under FDA review).
Device Name and Classification: 2.
| Trade Name: | AX Workstation DR-Viewer Software Option |
|---|---|
| Classification Name: | Accessory to Angiographic X-Ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1600 |
| Device Class: | Class II |
| Product Code: | LLZ |
-
Importer/Distributor Establishment Registration Number: 2240869 3. Facility:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830 -
Manufacturing Facility: 4. Siemens AG Bereich Med. Siemensstrasse l 91301 Forchheim Germany
Siemens Medical Systems, Inc.
Sales and Service
186 Wood Avenue South Iselin, NJ 08830
Tel: (732) 321-4500 Fax: (732) 494-2250
1
SIEMENS
Contact Person: છે.
Ms. Malgorzata Stanek Senior Technical Specialist Fax: (732) 321-4841 Phone: (732) 321-3950
Substantial Equivalence: 6.
The AX Workstation DR-Viewer Software Option uses a series of images of the anatomy (i.e. spine, legs, colon) generated with a radiographic, fluoroscopic, or angiographic x-ray system, and reconstructs the images into a single composite image format. After reconstruction of the image, the software provides the user with various measurement tools and post-processing functions.
| The package is substantially equivalent to the following devices: | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------------------- |
| Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Philips EasyVision Family Workstation | ||
| Legs Option | K990455 | 5/12/99 |
| Philips Spine Option for Easy Vision | ||
| Workstation | K963980 | 12/23/96 |
Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and specific equivalence information is provided in Attachment 5.
7. 510(k) Summary:
In response to the requirements addressed by the SMDA of 1990 and 21 CFR § 807.92, I am enclosing, in Attachment 8, a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
8. Indications For Use:
The AX Workstation DR-Viewer Software Option offers the user the ability to visualize composite images of selected anatomy (i.e. spine, legs, colon). The images produced by the package, as well as the measurement tools of DR-Viewer, are intended to assist the physician in diagnosis and treatment of musculoskeletal disorders and conditions of the gastrointestinal tract.
The Indications for Use statement for the DR-Viewer Software Option is also provided in Attachment 9.
Truthful and Accurate Statement: 9.
A Premarket Notification Truthful and Accurate Statement is provided in Attachment 1.
10. Labeling:
Information about the predicate devices is provided in Attachment 6. The Draft Operating Manual for DR-Viewer is provided in Attachment 7.
2
SIEMENS
Confidentiality
All items marked "CONFIDENTIAL" may be trade secret, confidential commercial or financial information as defined in 21 CFR § 20.61. Siemens requests that FDA not make public disclosure of this information without prior consultation with Siemens as provided by 21 CFR § 20.45.
We would appreciate your earliest attention to this 510(k) submission. Should you have any additional questions, please contact Ms. Malgorzata Stanek at (732) 321-3950. Her fax number is (732) 321-4841.
Sincerely,
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
Attachments
18
3
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Ms. Malgorzata Stanek Senior Technical Specialist Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830
MAY - 7 2012
Re: K992925
Trade/Device Name: DR-Viewer Software Option for AX Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 27, 1999 Received: August 30, 1999
Dear Ms. Stanek:
This letter corrects our substantially equivalent letter of November 23, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
ATTACHMENT 9
INDICATIONS FOR USE
| 510(k) Number (if known): | K992425 |
|---|---|
| Device Name: | DR-Viewer |
Indications For Use:
The AX Workstation DR-Viewer Software Option offers the ability to
r the AX Workstation DR-Viewer Software of a gripe Jeas, colon). The in The AX Workstation DK-Viewel Software Open Ii.e. spine, legs, colon). The images
visualize composite images of selected anatony in tools of DR-Viewer, are visualize composite miages of sciecited maxestarement tools of DR-Viewer, are
produced by the package, as well as the mass of myser of myscylockeletal produced by the package, as well as and treatment of musculoskeletal disorders and gastrointestinal conditions.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Jawad 4. Gym
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992925
Prescription Use /
OR Over-The-Counter Use__
(Per 21 CFR 801.109)