CRADLE PACS

K033912 · Cradle Technology Corp. · LLZ · May 11, 2004 · Radiology

Device Facts

• Record ID: K033912
• Device Name: CRADLE PACS
• Applicant: Cradle Technology Corp.
• Product Code: LLZ · Radiology
• Decision Date: May 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CRADLE HIPAX PACS device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

Device Story

CRADLE HIPAX PACS is a Picture Archiving and Communication System (PACS) designed for medical imaging environments. It functions as a central hub for medical image management, utilizing a databank mainframe, file storage backup, and medical tomography interlink. The system ingests medical images from various modalities and interfaces, processes them for diagnosis, and archives them. It supports distribution to workstations, storage devices, and printers using DICOM or similar standards. Operated by trained medical professionals, physicians, nurses, and technicians, the system facilitates clinical workflow by enabling the display and manipulation of diagnostic images. It aids clinical decision-making by providing centralized access to patient imaging data across a healthcare facility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PACS software system; utilizes databank mainframe, file storage backup, and medical tomography interlink modules. Supports DICOM and similar standards for image distribution and connectivity. Architecture involves distributed server-based functional modules.

Indications for Use

Indicated for trained medical professionals, including physicians, nurses, technicians, and computer system professionals, for the manipulation, management, and display of medical images from various modalities.

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

• DVNET Mdv-PACS (K031816)

Submission Summary (Full Text)

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K0339/2

# 2. ADMINISTRATIVE INFORMATION

MAY 11 2004

## 2.1 510(k) Summary of Safety and Effectiveness

## (1) Submitter: CRADLE TECHNOLOGY CORP

6F, No. 59, Tung-Hsing Road, Taipei, 110, Taiwan, ROC Fax: [phone] Tel: [phone] http:// www.cradle.com.tw

Dr. Jen, Ke-Min, REG # 9616345 Contact: No.58, Fu Chiun Street, Hsin Chu City, 300, Taiwan, ROC Fax: [phone] Tel: [phone] e-mail: [e-mail]

(2) Device Name:

- Trade name: CRADLE HIPAX PACS .
- Common name: Medical Image Integrate System ●
- ●

| Device | system, image processing, radiological |
|--------------------|----------------------------------------------|
| Device Description | Picture archiving and communications system. |
| Medical Specialty | Radiology |
| Product Code | LLZ |
| Regulation Number | 892.2050 |

(3) Predicate Device:

- DVVNET International Technology Co., Ltd. .
- DVNET Mdv-PACS, K031816 ●

#### (4) Device Description:

CRADLE HIPAX PACS consists of databank mainframe, file storage backup system, medical tomography interlink, job query, image diagnose and archive, and medical information integral linking modules and subsystems.

- (5) Intended Use of Device:
The CRADLE HIPAX PACS device is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.

Typical users of this software system are trained medical professionals, computer physicians, nurses, technicians and system including professionals.

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- (6) Substantial Equivalence to Predicate Device:
- According to the above discussion and information, the new device and the predicate device utilize the similar technologies and design aspects. The subject device is very similar and performs the same clinical function as the predicate device. The main distinguishing characteristic of the subject device is the different functional distribution among the PACS system. Furthermore, this difference raises no safety and effectiveness hazard. Hence, they are considered to be substantially equivalent.
- (7) Safety:

Even though the functions are distributed among different servers between two products, whole functions can be executed in the same way for two The new product hence raises no new safety or effectiveness systems. hazard.

### (8) Conclusion:

According to the above discussion and information, the new device and the predicate device utilize the similar technologies and design aspects. The subject device is very similar and performs the same clinical function as the predicate device. The main distinguishing characteristic of the subject device is the different functional distribution among the PACS system. Furthermore, this difference raises no safety and effectiveness hazard. Hence, they are considered to be substantially equivalent.

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Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird with its wings spread, depicted in a minimalist, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2004

Cradle Technology Corp. % Dr. Jen, Ke-Min ROC Chinese-European Industrial Research Society No. 58. Fu-Chiun St., HSIN-CHU CITY, 300 CHINA (TAIWAN)

Re: K033912 Trade/Device Name: Cradle Hipax PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II

Product Code: 90 LLZ Dated: March 17, 2004 Received: March 22, 2004

Dear Dr. Jen, Ke-Min:

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 such additional controls. Existing major regulations affecting your device can be found in the Codc 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); 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.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/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

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K 03 39/2

## 2.2 FDA Indication for Use Form :

| Applicant : | CRADLE TECHNOLOGY CORP. |
|-----------------|-------------------------|
| 510(k) Number : | TO BE ASSIGNED |
| Device Name : | CRADLE HIPAX PACS |

### Indications for Use :

- The CRADLE HIPAX PACS device is intended for the manipulation, . management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards.
Typical users of this software system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

David R. Ingram

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number KC33912

Prescription Use Per 21 CFR 801.109

OR

Over-The-Counter (Optional Format 1-2-96)