(16 days)
No
The document describes a standard digital radiography system with image post-processing, but there is no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
The device is intended for generating radiographic images for diagnostic purposes, not for treating any condition.
Yes
The device is explicitly referred to as a "Digital Diagnostic Radiographic System" in its name and description, and its intended use is to generate "radiographic images of human anatomy" for a "qualified/trained doctor or technician," which is a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including a tube column with X-ray assembly, wall stand, patient table, high voltage generator, and acquisition and reviewing workstation. While it includes software for image processing, it is an integral part of a larger hardware system.
Based on the provided information, the DuraDiagnost is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "generating radiographic images of human anatomy." This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details a system with components like an X-ray tube, wall stand, patient table, and workstation for image acquisition and processing. These are all characteristic of an X-ray imaging system.
- Input Imaging Modality: The input modality is explicitly stated as "Digital Diagnostic Radiographic System."
- Anatomical Site: The device is used to image "human anatomy."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) outside of the body. IVDs are designed to perform tests on such specimens to provide information for diagnosis, monitoring, or screening.
The DuraDiagnost is a medical imaging device used for diagnostic radiography, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Product codes
KPR, MQB
Device Description
The Philips DuraDiagnost Digital Diagnostic Radiographic System (DuraDiagnost) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The Philips DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician
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
Non-clinical performance testing was performed to demonstrate compliance with international and FDA-recognized consensus standards and FDA Guidance documents. Verification/validation tests were also performed to address intended use, technical claims, requirement specifications, and risk management results. The study concluded that the Philips DuraDiagnost complies with the standards and meets acceptance criteria and is adequate for its intended use. Clinical study was not warranted as substantial equivalence was demonstrated through design features, indication for use, fundamental scientific technology, and safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. Above and to the right of the word, there is some handwritten text that reads "K14381 Page 1 of 12". The handwritten text is smaller and less distinct than the word "PHILIPS".
510(k) Summary of Safety and Effectiveness
.
JUN 1 2 2014
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92. .
| Date Prepared: | March 21, 2014 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| No. 258, Zhong Yuan Road, Suzhou Industrial Park, 215024 Suzhou, | |
| Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA | |
| Establishment Registration Number: Not registered yet | |
| Contact Person: | Gordon Shu |
| Regulatory Affairs Manager | |
| Phone: +86-512-67336804 | |
| Fax: +86-512-68018677 | |
| E-mail: Gordon.Shu@philips.com | |
| Trade Name: | DuraDiagnost |
| Common Name: | Digital Diagnostic Radiographic System |
| Classification: | Classification Name: Stationary X-Ray System |
| Classification Regulation: 21CFR §892.1680 | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Classification Product Code: KPR (System, X-Ray, Stationary) | |
| Subsequent Product Code: MQB (solid state x-ray imager (flat panel/digital imager)) | |
| Predicate Device 1: | Trade Name: Brivo XR385, Digital Diagnostic Radiographic System |
| Manufacturer: GE MEDICAL SYSTEM, LCC | |
| 510(k) Clearance: K103448 (August 12, 2011) | |
| Classification Regulation: 21 CFR, Part 892.1680 | |
| Classification Name: Stationary X-Ray System | |
| Classification Panel: Radiology | |
| Device Class: Class II | |
| Product Code: KPR |
1
Device Trade Name: Philips BuckyVision Predicate Manufacturer: Philips Medical Systems, Inc. 510(k) Clearance: K982795 (November 24,1998) Classification 21CFR §892.1680 Regulation: Classification Name: Stationary X-Ray System Classification Panel: Radiology Device Class: Class II KPR & MQB Product Code: ddRVersa™ Motion Trade Name: Predicate Device
Manufacturer: Swissray Medical AG 510(k) Clearance: K123005 (December 7, 2012) 21CFR $892.1680 Classification Regulation: Classification Name: Stationary X-Ray System
Classification Panel: Radiology
Device Class:
Class II
Device Code: KPR & MQB
Device description:
2:
3:
The Philips DuraDiagnost Digital Diagnostic Radiographic System (DuraDiagnost) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The Philips DuraDiagnost consist of the following components: Tube column with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
2
Indications Use:
for
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Summarv of the Technological Characteristics & Fundamental Scientific Technology:
The components of the Philips DuraDiagnost employ similar basic construction and fundamental scientific technology as provided with the currently marketed and predicate GE Brivo XR385 and Philips BuckyVision with regards to the functionality of the following components: Integrated tube column, patient table with a floating table top, high-voltage generator, dual-focus rotation anode X-Ray tube, manual beam limiting device, digital detector, wall stand and workstation for images post-processing, storage and viewing (See the comparison Table provided below, comparing the Philips DuraDiagnost to the currently marketed predicate devices). The outcome of this comparison demonstrates that the minor differences in the technological characteristics do not affect the safety or effectiveness of the Philips DuraDiagnost when compared to the currently marketed and predicate devices.
The wireless portable detector (Model No. 3543EZ) of the Philips DuraDiagnost is identical to the wireless portable detector (Model No. 3543EZ) of the currently marketed and predicate ddRVersaTM Motion (K123005 - December 7, 2012) - Swissray Medical AG and is manufactured by Trixell. Therefore, both the wireless portable detector of the Philips DuraDiagnost and the wireless portable detector of the currently marketed and predicate ddRVersa™ Motion employ identical fundamental scientific technology.
Based on the information provided above, the Philips DuraDiagnost is considered substantially equivalent to the currently marketed and predicate device, GE Brivo XR385 (K103448 - August 12, 2011) and Philips Bucky Vision (K982795 - November 24, 1998) in terms of fundamental scientific technology. With regards to wireless portable detector, the Philips DuraDiagnost is considered substantially equivalent to the currently marketed and predicate ddRVersa™ Motion (K123005 - December 7, 2012) - Swissray Medical AG in terms of fundamental scientific technology.
3
. . .
| Feature | Currently
marketed and
Predicate GE Brivo
XR385 (K103448) | Currently marketed
and Predicate Philips
BuckyVision
(K982795) | Currently marketed
and Predicate Swissray
ddRVersa™ Motion
(K123005) | Philips
DuraDiagnost | Comparison Results |
|-----------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design characteristic | Toshiba E7843X | RO 1750 & SRO 33100 | Note: The currently
marketed and predicate
Swissray ddRVersa™
Motion (K123005 –
December 7, 2012) is only
used to demonstrate
substantial equivalence to
the wireless portable
detector (model 3543EZ)
of the Philips
DuraDiagnost, since it is
manufactured by the same
manufacturer Trixell. | RO 1750 & SRO 33100 | Identical. The Philips
DuraDiagnost and the currently
marketed and predicate Philips
BuckyVision both use the
identical X-ray tube. Thus,
demonstrating SE. |
| Max Tube
Voltage | 150kV | 150kV | | 150kV | Identical. Thus, demonstrating
SE. |
| Focal spot
size | 0.6mm/1.2mm | 0.6mm/1.2mm | | 0.6mm/1.2mm | Identical. Thus, demonstrating
SE. |
| Tube Max
power | 50K W | 50KW/100KW | | 50KW/100KW | Identical. The Philips
DuraDiagnost and the currently
marketed and predicate Philips
BuckyVision both use the
identical X-ray tube. Thus,
demonstrating SE. |
| Anode Type | Rotation | Rotation | | Rotation | Identical. Thus, demonstrating
SE. |
Philips DuraDiagnost 510 (K)
510(K) Summary
.
・
Page 4 of 12
:
4
:
| Generator | Max Power | KV range | Milli ampere
sec (mAs)
product | Collimator
Operation
Mode | | Shape of
Beam | Detector
Type | X-ray
Scintillator
Material | Image Area | | | |
|-------------------------------------------------------------------------------------------|----------------|----------|------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|-----------------------------|-------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Unknown | 50KW | 40-150 | 0.02 mAs-512
mAs(with AEC
control) | Manual collimation | | Rectangular | Digital Detector (Fixed) | Gadolinium
Oxysulphide (GdOS) | 40.4cm x 40.4 cm | | | Identical. Thus, demonstrating
SE. |
| EMD Technologies,
M-CABINET CXA 50kW,
M-CABINET CXA 65kW,
M-CABINET CXA 80kW | 50KW/65KW/80KW | 40-150 | 0.5 mAs-600 mAs (with
AEC control) | Motorized automatic
collimation or manual
collimation | Note: The currently
marketed and predicate
Swissray ddRVersaTM
Motion (K123005 –
December 7, 2012) is only
used to demonstrate
substantial equivalence to | Rectangular | Digital Detector (Fixed) | Cesium Iodide | 42.5 cm x 42 cm | the wireless portable
detector (model 3543EZ)
of the Philips
DuraDiagnost, since it is
manufactured by the same
manufacturer Trixell. | | |
| EMD Technologies,
M-CABINET CXA
50kW, M-CABINET
CXA 65kW, M-
CABINET CXA 80kW | 50KW/65KW/80KW | 40-150 | 0.5 mAs-600 mAs (with
AEC control) | Manual collimation | Identical. The Philips
DuraDiagnost and the currently
marketed and predicate Philips
BuckyVision both use the
identical Generator. Thus,
demonstrating SE. | Rectangular | Digital Detector (Wireless) | Cesium Iodide | 42.4cm x 34.8cm
(wireless) | | Digital Detector (Fixed
& Wireless) | Identical. The Fixed and
Wireless Portable Detector of the
Philips DuraDiagnost is
identical to the currently
marketed and predicate GE's
Brivo XR385, Philips Bucky
Vision and Swissray's
ddRVersa™ Motion in terms of
the type of the detector. Thus,
demonstrating SE. |
| | | | | | Identical. The Philips
DuraDiagnost and the currently
marketed and predicate Philips
BuckyVision both use the
identical power. Thus,
demonstrating SE. | | | GdOS(Fixed)
Cesium
Iodide(Wireless) | 43cm x 43cm(Fixed)
42.4cm x 34.8cm
(wireless) | | | Identical. The Fixed and
Wireless Portable Detector of the
Philips DuraDiagnost and the
currently marketed and predicate
GE's Brivo XR385 and
Swissray's ddRVersa™ Motion
utilize identical scintillator
material fabricated from GdOS
and Cesium Iodide, respectively.
Thus demonstrating SE. |
| | | | | | Identical. Thus, demonstrating
SE. | | | | | | | Identical for Wireless Portable
Detector. |
| | | | | | Identical. The Philips
DuraDiagnost and the currently
marketed and predicate Philips
BuckyVision both use the
identical mAs. Thus,
demonstrating SE. | | | | | | | The Wireless Portable Detector
of the Philips DuraDiagnost and |
| | | | | | Same. The Philips
DuraDiagnost and the currently
marketed and predicate GE's
Brivo XR385 both use the
manual collimation mode. Thus,
demonstrating SE. | | | | | | | |
Philips DuraDiagnost 510 (K)
.
Page 5 of 12
.
5
Philips DuraDiagnost 510 (K)
Page 6 of 12
"
6
| Image
Matrix Size | 2048 x 2048 | the currently marketed and
predicate Swissray's
ddRVersa™ Motion utilize
identical image area. Thus
demonstrating SE.
Similar for Fixed Detector. |
|----------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2874 x 2840 | The slight differences between
the image area of the Philips
DuraDiagnost and the currently
marketed and predicate predicate
Philips BuckyVision and GE's
Brivo XR385 are not anticipated
to significantly alter the
diagnostic image quality. Thus,
demonstrating SE. |
| | 2866 x 2350 (wireless) | Identical for Wireless Portable
Detector. |
| | 2874 x 2869 (Fixed) | |
| | 2866 x 2350 (wireless) | The Wireless Portable Detector
of the Philips DuraDiagnost and
the currently marketed and
predicate Swissray's
ddRVersa™ Motion utilize
identical image matrix size. Thus
demonstrating SE.
Similar for Fixed Detector.
The slight differences between
the image matrix size of the
Philips DuraDiagnost and the
currently marketed and predicate |
(
PHILIPS
.
Philips DuraDiagnost 510 (K)
Summary
Page 7 of 12
7
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- | |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | |
| Class Concession | Comments of Children Comments of Children | |
| I | | |
| - | | |
| | l | |
| | l | |
| Analog / Digital (A/D) conversion | 14 bits | 16 bits | 16 bits | 16 bits |
|---|---|---|---|---|
| Identical. The Philips DuraDiagnost and the currently marketed and predicate Philips BuckyVision and Swissray's ddRVersa™ Motion all use the same A/D conversion. Thus, demonstrating SE. | Note: The currently marketed and predicate Swissray ddRVersa™ Motion (K123005 – December 7, 2012) is only used to demonstrate substantial equivalence to the wireless portable detector (model 3543EZ) of the Philips DuraDiagnost, since it is manufactured by the same manufacturer Trixell. | predicate Philips BuckyVision and GE's Brivo XR385 are not anticipated to significantly alter the diagnostic image resolution. Thus, demonstrating SE. | ||
| Source to Image Distance (SID) | Table: 50-110cm; | |||
| Wallstand: 100-180cm | SID depends on different configurations, because BuckyVision is ceiling suspension X-ray system. | Table: 40-115cm; | ||
| Wallstand: 110-245cm | The slight differences between the SID of the proposed DuraDiagnost and the currently marketed and predicate GE's Brivo XR385 are not anticipated to significantly alter the application usage. Thus, demonstrating SE. |
Philips DuraDiagnost 510 (K)
Summary S10(K) Summary
ﺮ
Page 8 of 12
8
| External connectivity | ||||
|---|---|---|---|---|
| DICOM | DICOM 3.0 compatible | DICOM 3.0 compatible | DICOM 3.0 compatible | Same. Thus, demonstrating SE. |
| Software platform | Unknown | Eleva workspot | ||
| (K063781-January 05, 2007) | Eleva workspot | Same. The Philips | ||
| DuraDiagnost and the currently | ||||
| marketed predicate Philips | ||||
| BuckyVision both use the same | ||||
| software platform. Thus, | ||||
| demonstrating SE. | ||||
| Note: The currently | ||||
| marketed and predicate | ||||
| Swissray ddRVersa™ | ||||
| Motion (K123005 – | ||||
| December 7, 2012) is only | ||||
| used to demonstrate | ||||
| substantial equivalence to | ||||
| the wireless portable | ||||
| detector (model 3543EZ) | ||||
| of the Philips | ||||
| DuraDiagnost, since it is | ||||
| manufactured by the same | ||||
| manufacturer Trixell. | Note: The currently | |||
| marketed and predicate | ||||
| Swissray ddRVersa™ | ||||
| Motion (K123005 – | ||||
| December 7, 2012) is only | ||||
| used to demonstrate | ||||
| substantial equivalence to | ||||
| the wireless portable | ||||
| detector (model 3543EZ) | ||||
| of the Philips | ||||
| DuraDiagnost, since it is | ||||
| manufactured by the same | ||||
| manufacturer Trixell. |
hilips DuraDiagnost 510 (K)
.
. ............................................................................................................................................................................
9
Summary of Nonclinical Performance Data:
Non-clinical performance testing performed on the Philips DuraDiagnost demonstrates compliance with the following International and FDA-recognized consensus standards and FDA Guidance documents:
- AAMI / ANSI ES60601-1: 2005/(R)2012 and C1:2009/(R)2012 . and, a2:2010/(r)2012 (consolidated text) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-3 Edition 2.0 2008-01. Medical electrical . equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment.
- . IEC 60601-2-28 Edition 2.0 2010-03, Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis.
- . IEC 60601-2-54 Edition 1.0 2009-06, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
- IEC 62304 First edition 2006-05, Medical device software -. software life cycle processes.
- ISO 14971 Second edition 2007-03-01, Medical devices -. Application of risk management to medical devices.
- IEC 62366 Edition 1.0 2007-10. Medical devices Application . of usability engineering to medical devices.
- CFR 1020.30 Diagnostic x-ray systems and their major . components.
- CFR 1020.31 Radiographic equipment. ●
10
- Device specific guidance document, entitled "Guidance for the . Submission of 510(k)'s for Solid State X-ray Imaging Devices - August 6, 1999."
- FDA's Guidance document entitled, "Guidance for the . Content of Premarket Submissions for Software Contained in Medical Devices - May 11, 2005."
- FDA guidance document entitled, "Radio Frequency Wireless . Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff - August 13, 2013."
- FDA draft guidance document entitled, "Pediatric Information . for X-ray Imaging Device Premarket Notifications issued on May 10, 2012."
Additionally, verification / validation tests have been performed to intended use, the technical claims, requirement address specifications and the risk management results. The test results demonstrate that Philips DuraDiagnost:
- Complies with the aforementioned international and FDA-. recognized consensus standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its . intended use.
Therefore, the Philips DuraDiagnost is substantially equivalent to the currently marketed and predicate device, GE Brivo XR385 (K103448, Aug. 12, 2011) Philips BuckyVision (K982795-Nov.24, 1998) and ddRVersa™ Motion (K123005 - December 7, 2005) - Swissray Medical AG in terms of safety and effectiveness.
Clinical study was not warranted to support this 510(k) submission, since substantial equivalence to the currently marketed and predicate devices was demonstrated with the following attributes:
- . Design features;
Clinical Performance
Data:
- . Indication for use;
- Fundamental scientific technology; and .
- Safety and effectiveness. .
11
Image /page/11/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are all capitalized and evenly spaced. The word is black and stands out against a white background. The font is simple and modern.
Substantial Equivalence Conclusion:
The Philips DuraDiagnost is substantially equivalent to the currently marketed and predicate device GE Brivo XR385 (K103448. August 12, 2011) and Philips BuckyVision (K982795, November 24,1998) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness. With regards to the wireless portable detector, the Philips DuraDiagnost is considered substantially equivalent in terms of design and fundamental scientific technology to the currently marketed and predicate ddRVersa™ Motion (K123005 -December 7, 2005) - Swissray Medical AG.
Additionally, substantially equivalence was demonstrated with the following:
- . Non-clinical performance (verification / validation) tests, which complied with the requirements specified in the international and FDA recognized consensus standards;
- Tests identified in the FDA device specific guidance . document entitled, "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices - August 6, 1999." The results of these tests demonstrate that the Philips DuraDiagnost met the acceptance criteria, provides similar diagnostic image quality when compared with the predicate devices and is adequate for its intended use.
- Tests identified in the FDA guidance document entitled, . "Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff - August 13, 2013." The results of these tests demonstrate that the Philips DuraDiagnost met the acceptance criteria with regards to wireless technology used in the wireless portable Detector and is adequate for its intended use.
12
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/12/Picture/1 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2014
Philips Healthcare (Suzhou) Co., Ltd. % Mr. Gordon Shu Regulatory Affairs Manager No. 258, Zhong Yuan Road Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K141381 Trade/Device Name: Duradiagnost Regulation Number: 21 CFR 892.1680 Regulation Name: DuraDiagnost radiographic system Regulatory Class: II Product Code: KPR, MQB Dated: May 20, 2014 Received: May 28, 2014
Dear Mr. Shu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
13
Page 2—Mr. Gordon Shu
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
ាប់
Sincerely yours.
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
14
Indications for Use
510(k) Number (if known)
Device Name
DuraDiagnost
Indications for Use (Describe)
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
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