(15 days)
No
The document describes a standard PACS system for image management and processing, with no mention of AI, ML, or related technologies.
No
The device is a software package for managing, viewing, and processing medical images, not for directly treating or diagnosing patients.
No
This device is a software package for managing, viewing, and archiving medical images (PACS system), not for generating a diagnosis.
Yes
The device description explicitly states that ESSENPACS is a "software package" and a "software application" that manages medical images within a PACS environment. There is no mention of accompanying hardware components being part of the device itself.
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: ESSENPACS is a software package for managing and viewing medical images (like CT, MRI, X-ray). It deals with images generated by imaging equipment, not with analyzing biological samples.
- Intended Use: The intended use clearly states its purpose is for "acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images." This is related to medical imaging, not in vitro testing.
- Device Description: The description reinforces its role as a "distributed image management system."
- Input: The inputs are images from various imaging modalities, not biological samples.
Therefore, ESSENPACS falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ESSENPACS is a software package intended for acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images (including mammographic images). It receives digital images and data from various sources (including CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Product codes
LLZ
Device Description
ESSENPACS is a DICOM-compliant and server/client architectural software application. It is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. ESSENPACS is implemented on base of the Digital Imaging and Communication in Medicine (DICOM) standard. Therefore, the system provides communications of images and relevant information such as patient demographics and examination data between DICOM-compliant imaging devices and itself.
ESSENPACS is software application used for handing images and relevant information. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including physicians, nurses, and technicians.
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
Ko 5/081
MAY 1 2 2005
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Information
Mr. Hunpyo Hong
Chief Technology Officer and President
CYMED Engineering Inc.
6F. Dongwon-Bldg., #126
Bangyi-Dong. Songpa-Ku,
SEOUL, KOREA
TEL: 82-2-425-3711
Trade Name, Common Name and Classification
| Trade Name: | ESSENPACSTM |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 LLZ |
| Name: | System, Image Processing |
Predicate Device
| Manufacturer : | INFINITT CO., LTD. |
|---|---|
| Device : | STARPACS TM |
| 510(k) Number : | K011013 |
| Date Received : | 03/31/2003 |
| Decision Date : | 04/17/2003 |
| Decision : | Substantially Equivalent |
| Panel Code device reviewed by : | Radiology |
| Panel Code device classified by : | Radiology |
| Product Code : | LLZ |
| Classification : | Class II - 892.2050 LLZ |
Device Description
ESSENPACS is a DICOM-compliant and server/client architectural software application. It is a distributed image management system that manages the viewing, retrieval, manipulation, and distribution of medical images within a Picture Archiving and Communication System (PACS) environment. ESSENPACS is implemented on base of the Digital Imaging and Communication in Medicine (DICOM) standard. Therefore, the system provides communications of images and relevant information such as patient demographics and examination data between DICOM-compliant imaging devices and itself.
l
1
Indications for Use
ESSENPACS is a software package intended for acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images (including mammographic images). It receives digital images and data from various sources (including CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Technological Characteristics
ESSENPACS is software application used for handing images and relevant information. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.
Conclusion:
The 510(k) Pre-Market Notification for ESSENPACS ™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
ESSENPACS ™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".
2
. ﺗﻢ
Image /page/2/Picture/2 description: The image shows a circular logo with an eagle in the center. The eagle is facing left and has its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is written around the eagle in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 2 2005
Cymed Engineering, Inc. c/o Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K051081
Trade/Device Name: ESSENPACS™ Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 25, 2005 Received: April 27, 2005
Dear Mr. Lehtonen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have ro rowed one 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 the closed of the enactment date of the Medical Device Amendments, or to devices that have been ready 20, 1710, the claims 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 do not require approvisions provisions of the Act. The general controls provisions of the Act active, subjoct to the genual 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 (Premarket If your devise is chassisted to such additional controls. Existing major regulations affecting your Apployally, it they of seejest to 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 I Rase of advisou that your device complies with other requirements of the Act or any I DA nas mass and regulations administered by other Federal agencies. You must comply with all the I carates and reguirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 8017; good man assoif applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin hanceling your aver convalence of your device to a legally premarket nothication. THE I DA miding of Sacotanial Proper 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), please If you desire specific advice for your device of our as tassing of the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Theoration on your responsibilities under the Act from the 807.97). You may outlair other general mional on Jones Assistance at its toll-free number (800) Drisson of Small Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:
Device Name: ESSENPACS TM
Indications for Use:
ESSENPACS is a software package intended for acquisition, processing, archiving, transmitting and viewing DICOM Compliant medical images (including mammographic images). It receives digital images and data from various sources (including CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stancya broadron
d Radiological Device 510(k) Number