K Number
K070528
Device Name
PHILIPS ESSENTA DR
Date Cleared
2007-03-09

(14 days)

Product Code
Regulation Number
892.1680
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley). The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
Device Description
The Essenta DR is a multifunctional system, in which a swivel arm holds the x-ray tube and the x-raydetector. The generator, x-ray tube housing assembly, beam limiting device, deector, including the workstation for image processing and the optional mobile x-ay table (trolley) are known components. The geometry of the Essenta DR contains a central column, on which the height-adjustable and rotatable swivel arm is mounted. The rotatable detector and the rotatable x-ray tube with control section are mounted at the swivel arm. This enables the radiation beam to be adjusted to any position on a vertical plane. A second control section on the detector carrier allows positioning on the patient to be carried out at the detector itself. The vertical adjustment of the swivel arm, the rotation of the swivel arm and the SID adjustment are motorized. It esables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the auto-positioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.
More Information

Not Found

No
The description focuses on the mechanical and digital imaging components of a standard X-ray system, with no mention of AI or ML capabilities for image analysis, processing, or system control beyond basic auto-positioning.

No
The device is described as an X-ray system for diagnostic imaging, not for treating diseases or conditions.

Yes
A diagnostic device is one that helps to identify or determine the nature of a disease or condition. This device is an X-ray system used for "all routine radiographic exams" which are performed to diagnose various medical conditions.

No

The device description clearly outlines multiple hardware components including an X-ray tube, generator, detector, and a physical swivel arm system, indicating it is a hardware-based medical device with integrated software for image processing and control.

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

Here's why:

  • IVD devices are used to examine specimens taken from the human body. The Essenta DR is an X-ray system used for imaging the human body directly.
  • The intended use describes radiographic examination of patients. This involves generating images of internal structures using X-rays, not analyzing biological samples.
  • The device description details the physical components of an X-ray machine. It focuses on the X-ray tube, detector, and positioning mechanisms, which are characteristic of imaging systems, not laboratory diagnostic equipment.

Therefore, the Essenta DR falls under the category of medical imaging devices, not IVD devices.

N/A

Intended Use / Indications for Use

The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley). The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.

Product codes

MQB, IZL

Device Description

The Essenta DR is a multifunctional system, in which a swivel arm holds the x-ray tube and the x-raydetector. The generator, x-ray tube housing assembly, beam limiting device, deector, including the workstation for image processing and the optional mobile x-ay table (trolley) are known components. The geometry of the Essenta DR contains a central column, on which the height-adjustable and rotatable swivel arm is mounted. The rotatable detector and the rotatable x-ray tube with control section are mounted at the swivel arm. This enables the radiation beam to be adjusted to any position on a vertical plane. A second control section on the detector carrier allows positioning on the patient to be carried out at the detector itself. The vertical adjustment of the swivel arm, the rotation of the swivel arm and the SID adjustment are motorized. It esables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the auto-positioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

K982795

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

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5 510(k) Summary

Page 4 January 31, 2007

Image /page/0/Picture/3 description: The image shows a handwritten date and number. The date "January 31, 2007" is written at the top of the image. Below the date, the number "K070528" is written in a larger, bolder font.

In accordance with the requirements of 21 CFR 807.92

1. Submitted by

Philips Medical Systems 22100 Bothell Eventt Highway Bothell. Washington 98021-8431 Establishment Registration No. 1217116 Contact: Lynn Hamer Phone: (25) 487-7312 Fax: (425) 487-8666 Date prepared: Jauary 31, 2007

  1. Manufacturer:

Philips Medical Systems DMC GmbH Roenigenstrasse24 Hamburg, Germany D-22335 Establishment Registration No. 3003768251

3. Device name andelassification

Trade name: Essena DR Classification name: Stationary X-ray system and Solid State X-ray Imager Classification pand: Radiology devices Regulatory status: Class II Device classification reg. nr .: 21CFR 892.1680 and 21 CFR 892.1650

4. Predicate device

Trade name: PHIUPS BUCKY VISION Manufacturer: PHILIPS MEDICAL SYSTEMS K-Number: K982795

5. Description

The Essenta DR is a multifunctional system, in which a swivel arm holds the x-ray tube and the x-raydetector. The generator, x-ray tube housing assembly, beam limiting device, deector, including the workstation for image processing and the optional mobile x-ay table (trolley) are known components. The geometry of the Essenta DR contains a central column, on which the height-adjustable and rotatable swivel arm is mounted. The rotatable detector and the rotatable x-ray tube with control section are mounted at the swivel arm. This enables the radiation beam to be adjusted to any position on a vertical plane. A second control section on the detector carrier allows positioning on the patient to be carried out at the detector itself. The vertical adjustment of the swivel arm, the rotation of the swivel arm and the SID adjustment are motorized. It esables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the auto-positioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command arm.

Summary page 1 of 2

MAR 0 9 2007

1

6. Intended Use

The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trollcy). The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.

7. Comparison to predicate device

The Essenta DR does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Essenta DR to be substantially equivalent with the predicate device.

Summary page 2 of 2

2

Image /page/2/Picture/0 description: The image contains a logo with text and a symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around a symbol. The symbol appears to be an eagle-like figure with stylized lines, possibly representing wings or feathers. The logo is in black and white.

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

Phillips Medical Systems % Mr. Marc M. Mouser Senior Project Engineer/Reviewer Underwriters Laboratories, Inc. 2600 NW Lake Road CAMAS WA 98607

AUG 2 3 2013

Re: K070528 Trade/Device Name: Essenta DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB and IZL Dated: February 22, 2007 Received: February 23, 2007

Dear Mr. Mouser:

This letter corrects our substantially equivalent letter of March 9, 2007.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

3

medical device-related adverse events) (21 CFR 803); and good manufacturing practice mequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket with anow you to began manager of your antial equivalence of your device to a legally marketed nothroution. - The Device results in 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 Parts 801 and 11 you docuse openers the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

4

Indications for Use

510(k) Number (if known):

K070528

Device Name: Essenta DR

Indications For Use:

The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.

It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley).

The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.

Prescription Use __ × (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
5.(K) Number
2070528
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