AX WORKSTATION

K992073 · Siemens Medical Solutions USA, Inc. · LLZ · Sep 9, 1999 · Radiology

Device Facts

• Record ID: K992073
• Device Name: AX WORKSTATION
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

AX Workstation is a digital review workstation for angiographic images. It accepts digital x-ray images, CT scans, and MR scans as input. The device provides image processing tools including filtering, gray scale windowing, zoom/roam, subtraction, and quantification. It is used outside the exam room by physicians to assist in diagnosis and treatment planning. The workstation also supports reporting and archival functions. By enabling multimodality viewing on a single platform, it facilitates comprehensive patient assessment, aiding clinical decision-making for vascular interventions and disease management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital workstation for image review and processing. Features include filtering, gray scale windowing, zoom/roam, subtraction, and quantification. Supports multimodality integration (angiography, CT, MR). Connectivity includes archival and reporting functions. Operates as a standalone workstation for use outside the exam room.

Indications for Use

Indicated for use by physicians to review and process angiographic images for diagnosis and treatment planning of vessel malformations, diseases, or injuries. Supports multimodality viewing of CT and MR images for the same patient. Prescription use only.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Siemens TOP ACOM Station (K945293)
• Camtronics Analytical Review Station (K955519)

Submission Summary (Full Text)

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#### SEP 9 1999

### Summary Of Safety and Effectiveness

K992073

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: [phone] Fax: [phone] E-Mail: [e-mail]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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# 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__________________________________________________________________________________________________________________________________________________________