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

• K Number: K091364
• Device Name: DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
• Manufacturer: OEHM UND REHBEIN GMBH
• Date Cleared: 2009-12-11 ( 217 days)
• Product Code: LLZ
• Regulation Number: 892.2050

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 Description

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. 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.

Predicate Devices

K070618

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing, archiving, and display functions common in PACS systems, with no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that learn from data.

Therapeutic

No
The device is described as a software system for administering, archiving, processing, and displaying medical image data for diagnosis, rather than for treating a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the software systems are for "processing, improvement and compression of medical image data for diagnosis" and that "The data is displayed on a computer monitor for diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states that dicomPACS® DX-R can control X-ray generators, which implies interaction with hardware beyond just software processing and display.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
• Device Function: The description clearly states that dicomPACS® and dicomPACS® DX-R are software systems for the administration, archiving, processing, and display of medical image data for diagnosis. This data is acquired from imaging modalities (like X-ray) or imported directly.
• No Specimen Handling: There is no mention of the device interacting with or analyzing biological specimens from the human body. Its function is solely related to the management and manipulation of medical images.

Therefore, the intended use and device description align with a medical image management and processing system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

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.

New functionality provided:

1. Viewer-dicomWeb
2. Viewer-Prosthesis Module
3. 100% magnifying glass
4. MPR (multi-planar reconstruction)
5. Hanging protocol section area
6. Generator Control
7. CR/DR acquisition
8. Raw data processing
9. Image overlay configuration
10. X-ray assistant
11. Examination tree
12. Virtual keyboard

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

DICOM imaging modalities, CR/DR acquisition

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified medical personnel

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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K070618

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Regulation Number and Section

§ 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).

Summary

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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:

:

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| Address: | Oehm und Rehbein GmbH
Waldemarstr. 20 g/h
18057 Rostock
GERMANY |
|---------------------------------------|--------------------------------------------------------------------------|
| Establishment Registration
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
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

1

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
[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

5

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