DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4

K091364 · Oehm Und Rehbein GmbH · LLZ · Dec 11, 2009 · Radiology

Device Facts

• Record ID: K091364
• Device Name: DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
• Applicant: Oehm Und Rehbein GmbH
• Product Code: LLZ · Radiology
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data. dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to adjustment of window leveling, rotation, zoom, and measurements. dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

Device Story

Software systems for administration, archiving, processing, and compression of medical images. Inputs include DICOM images from modalities or direct imports. dicomPACS® DX-R includes additional functionality for X-ray generator control, CR/DR acquisition, and raw data processing. Used by qualified medical personnel in clinical settings to view and manipulate images (window leveling, rotation, zoom, measurements, MPR). Output displayed on computer monitors for diagnostic purposes. Supports clinical decision-making by providing tools for image enhancement and management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based PACS and radiological image processing system. Features include DICOM compliance, multi-planar reconstruction (MPR), generator control, and CR/DR acquisition. Operates on standard computer hardware. No specific materials or energy sources defined as it is a software-only device.

Indications for Use

Indicated for qualified medical personnel to administer, archive, process, and diagnose medical image data. Not approved for mammographic image acquisition. Mammographic images require 5 MP resolution monitors for interpretation.

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

• dicomPACS® 5 (K070618)

Submission Summary (Full Text)

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તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણ

dicomPACS® I dicomPACS® - DX-R Special 510(k)

November 10, 2009

510(k) Summary

# DEC 1 1 2009

# 1. Administrative Information

### Reason for Submission:

### 510(k) Notification for dicomPACS® 5.2 and dicomPACS DX-R® 1.6

#### Submitter:

:

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

.

| Address: | Oehm und Rehbein GmbH<br>Waldemarstr. 20 g/h<br>18057 Rostock<br>GERMANY |
|---------------------------------------|--------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 3006542593 |
| Submission contact person: | Mr. Wolfgang Moeller |
| Contact telephone: | [phone] |
| Contact e-mail: | [e-mail] |
| Common device name: | PACS (Picture Archiving and Communications System) |
| Classification: | Class II |
| Regulation no.: | 892.2050 |
| Product code: | LLZ |
| US Agent: | Alan Schwartz |
| US Agent company: | mdi Consultants, Inc. |
| US Agent address: | 55 Northern Blvd. Suite 200, Great Neck, NY 11021 |
| US Agent telephone: | 516-482-9001 |
| Substantial equivalent device: | |
| Device Name(s): | dicomPACS® 5.2<br>dicomPACS® DX-R 1.6 |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Common Product Name: | Radiological Image Processing System |
| Predicate device: | |
| Device Name(s): | dicomPACS® 5 |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Common Product Name: | Radiological Image Processing System |
| 510(k) Number: | K070618 |

Executive Summary

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## 2. Indications for Use

dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to, adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

## 3. Functional Comparison

The software comes in two varieties - as dicomPACS® 5.2. and as dicomPACS® DX-R 1.6. While dicomPACS® DX-R 1.6 provides some functionality like generator control, CR/DR acquisition and raw data processing, dicomPACS® does not have these functions. The following table gives you an overview which configuration provides which new functionality.

The functions as given in the previous Premarket Notification, K070618, remain valid. Please find the 510(k) for the previous Premarket Notification in Sec. 11-A of this submission.

There have been modifications since version 5 of the software. The following table provides a list of all modifications that have taken place between dicomPACS® in version 5 and dicomPACS® in version 5.2 and dicomPACS® DX-R in version 1.6.

| | Komponente: | dicomPACS | dicomPACS DX-R |
|-----|---------------------------------------------------|-----------|----------------|
| 1. | Viewer-dicomWeb | X | X |
| 2. | Viewer-Prosthesis Module | X | X |
| 3. | 100% magnifying glass | X | X |
| 4. | MPR (multi-planar reconstruction) | X | X |
| 5. | Hanging protocol section area | X | X |
| 6. | Generator Control<br>[Accession No.: 0910034-000] | - | X |
| 7. | CR/DR acquisition | - | X |
| 8. | Raw data processing | - | X |
| 9. | Image overlay configuration | - | X |
| 10. | X-ray assistant | - | X |
| 11. | Examination tree | - | X |
| 12. | Virtual keyboard | - | X |

Table 1: Modifications to different configurations

#### Executive Summary

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## 4. Significant Change

As layed out in the "List of Modifications" in Sec. 10 of this submission some of the current changes are significant according to the FDA memorandum #K97-1 "Deciding When to Submit a 510(k) for a Change to an Existing Device". These significant changes are

No. 4 - Multiplanar Reconstruction (MPR),

No. 7 - CR/DR acquisition, and

No. 8 - Raw data processing.

## 5. Substantial Equivalence Conclusion

None of the modifications alter the Indications for Use in a significant way, nor the fundamental scientific technology, and do not introduce a fundamentally new scientific technology.

We therefore believe that the information presented in this Special 510(k) demonstrate that the product is safe for the patient, user, and bystander and does not raise any new questions regarding safety and effectiveness.

#### Executive Summary

Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Oehm und Rehbein GmbH % Mr. Alan Schwartz Official Correspondent mdi Consultants. Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

# DEC 1 1 2009

Re: K091364

Trade/Device Name: dicomPACS® 5.2 / dicomPACS® DX-R 1.6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 18, 2009 Received: December 2, 2009

Dear Mr. Schwartz:

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, 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Device Name: __ dicomPACS® 5.2 / dicomPACS® DX-R 1.6

Indications for Use:

dicomPACS® and dicomPACS®DX-R are software systems for the administration, archiving, processing, improvement and compression of medical image data for diagnosis. The images are either acquired from imaging modalities via DICOM or imported directly. All images are archived in a database as DICOM compliant files. The data is displayed on a computer monitor for diagnosis. dicomPACS® and dicomPACS® DX-R also provides services for administering the data.

dicomPACS® DX-R can control X-ray generators. dicomPACS®DX-R is not approved for the acquisition of mammographic image data.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Functions to be carried out using dicomPACS® and dicomPACS® DX-R are, for example, but not limited to adjustment of window leveling, rotation, zoom, and measurements.

dicomPACS® and dicomPACS®DX-R are meant to be used by qualified medical personnel only. All users must be qualified to create and diagnose radiological image data.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

lomi mzh
(Division Sign-Off)

-Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K091364

Indications for Use Statement