(204 days)
The Multix Select DR is a digital system used for making X-ray exposures of the head, spinal column, abdomen, thorax (lungs), internal organs and extremities with/without using conventional film/screen and CR -systems, and may be used on pediatric, adult and bariatric patients. The Multix Select DR system is not meant for mammography.
Multix Select DR is a product sharing same image system platform with Siemens' Multix Fusion x-ray system cleared under Premarket Notification K121513 on 08/10/2012, but target to low end DR market segment. The Multix Select DR system consists of radiologic table, x-ray generator, x-ray tube, flat panel detector (mobile (wired)), imaging system and Bucky-wall stand. The Multix Select DR offers the following system configurations: A digital radiography system with a mobile (wired) flat panel detector. The key components are a Patient Table and a Bucky wall stand which are available in different configurations. The x-ray tube is a Single Tank Tube Assembly and mounted in a column integrated on the patient table. A manual movement of the x-ray tube is available.
The provided document does not describe a study to prove acceptance criteria for a new device's performance in the way typically found for AI/ML devices. Instead, this is a 510(k) premarket notification for a traditional medical device (an X-ray system), where "acceptance criteria" primarily refer to conformance with established safety and performance standards rather than clinical performance metrics like sensitivity or specificity for an AI algorithm.
The document argues for substantial equivalence to a predicate device (Multix Fusion K121513) based on similar indications for use and technological characteristics. The "performance testing" described is focused on compliance with regulatory standards for electrical safety, mechanical safety, EMC, radiation performance, software lifecycle, and quality systems.
Therefore, many of the requested fields (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study results) are not applicable or not provided in this context.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness Equivalence | Substantial equivalence to predicate device (Multix Fusion K121513) based on: - Same Indications for Use - Same or similar comparable components (X-ray tube, collimator, table, X-ray Generator, Bucky wall stand, Digital Imaging system, Flat panel detector) | The Multix Select DR is presented as substantially equivalent to the Multix Fusion (K121513). Differences in Generator (55kW vs 55/65/80kW), X-ray Tube (OPTIPHOS 135/30/55R vs OPTITOP 150/40/80HC-100), Collimator (Manual vs Manual or automatic), Table (Floating vs Lifting & Floating), Bucky wall stand (Manual vertical movable, Non-tiltable tray vs Manual vertical movable, tiltable tray), and Flat Panel Detector (DRZ+ Gadox a-Si vs Cesium iodide CsI a-Si) are stated not to affect safety or effectiveness, supported by verification, validation, and risk management. |
| Voluntary Standards Conformance (General) | - IEC 60601-1: General Requirements for Safety (1988, Amend 1,2) - IEC 60601-1-1: Safety requirements for medical electrical systems (2000) - IEC 60601-1-2: Electromagnetic Compatibility (Ed 2:2001, Amend 1:2004) - IEC 60601-1-3: Radiation protection for diagnostic X-ray equipment (First Ed. 1994-07 & Ed. 2.0 2008-01) - IEC 60601-1-4: Programmable electrical medical systems, edition 1.1 (2000) - ISO 14971: Application of risk management to medical devices (2007) - IEC 62304 Ed. 1.0: Medical device software - Software life cycle processes - ISO 10993-1: Biological evaluation of medical devices (2009) - IEC 60601-1-6: Usability (2004) | Siemens "certify to conformance" and "hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards" for all listed voluntary standards. Performance data is provided in Original 510k submission Appendix G (not included in the extract). |
| Voluntary Standards Conformance (Radiology) | - IEC 60601-2-7: Safety of high-voltage generators of diagnostic X-ray generators (1998) - IEC 60601-2-28: Safety of X-ray source assemblies and X-ray tube assemblies (2010) - IEC 60601-2-32: Safety of associated equipment of X-ray equipment (1994) - NEMA PS 3.1-3.20 (2011): Digital Imaging and Communications in Medicine (DICOM) - IEC 60601-2-54: Basic safety and essential performance of X-ray equipment for radiography and radioscopy (Edition 1.0) | Siemens "certify to conformance" and "hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards" for all listed voluntary standards. |
| Federal X-ray Performance Standards (21 CFR) | - 21 CFR 1020.30: Manufacturer's Responsibility, Identification, Information to assemblers/users, Warning label, Leakage Radiation, Radiation from components, Beam Quality, Aluminum equivalent - 21 CFR 1020.31: Control and indication of technique factors, Reproducibility, Linearity, Field limitation and alignment (mobile, portable, stationary), Field indication and alignment (stationary), Beam-on indicators | Siemens "certifies that the subject device the Multix Select DR will meet the applicable requirements of the FDA Performance Standards for lonizing Radiation application for diagnostic X-Ray systems and their major components." |
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The submission focuses on substantial equivalence through component comparison and conformance to engineering/safety standards, not clinical performance testing with a "test set" of patient data for image interpretation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth establishment by experts for image interpretation is not mentioned as part of this 510(k) submission.
4. Adjudication method for the test set:
- Not applicable/Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an X-ray system, not an AI/ML diagnostic algorithm designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- Not applicable in the context of clinical performance of an AI model. For the safety and performance testing, the "ground truth" would be the established specifications and requirements of the various IEC, ISO, and 21 CFR standards.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable.
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APR 1 0 2014
SIEMENS
Multix Select DR 510(k) K132934 Al Response
510(k) Summary: Multix Select DR X-ray System
Siemens Medical Systems, Inc. Company: 1 Valley Stream Parkway Malvern, PA 19355
Date Prepared: March 12, 2014
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807,92.
1. General Information:
Importer / Distributor: Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number: 2240869
Location of Manufacturing Site: Siemens AG Medical Solutions X-Ray Products Henkestrasse 127 DE-91052 Erlangen Establishment Registration Number: 3002808157
Manufacturer:
Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road, Shanghai 201318, China Headquarters: Siemens AG Wittelsbacherplatz 2 D-80333 Munich 2, Germany Establishment Registration Number: 3003202425
2. Contact Person:
Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway D-02 Malvern, PA 19355 Fax: (610) 448-1787 Phone: (610) 448 -3536
Email: patricia.d.jones@siemens.com
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- Device Name and Classification: Trade Name: . Classification Name: Classification Panel: Radiology Classification Regulation: Device Class: Class II Product Code: 90 KPR
- Legally Marketed Predicate Device 4. Trade Name: 510(k) #: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
Multix Select DR Stationary X-Ray System 21 CFR §892.1680
Multix Fusion K121513 August 10, 2012 Stationary X-Ray System Radiology 21 CFR §892.1680 Class II 90 KPR
Device Description: ·
Select DR is a product sharing same image system platform with Multix Siemens' Multix Fusion x-ray system cleared under Premarket Notification K121513 on 08/10/2012, but target to low end DR market segment. The Multix Select DR system consists of radiologic table, x-ray generator, x-ray tube, flat panel detector (mobile (wired)), imaging system and Bucky-wall stand.
The Multix Select DR offers the following system configurations:
- A digital radiography system with a mobile (wired) flat panel detector, .
The key components are a Patient Table and a Bucky wall stand which are available in different configurations. The x-ray tube is a Single Tank Tube Assembly and mounted in a column integrated on the patient table. A manual movement of the x-ray tube is available.
Similar to the cleared Multix Fusion x-ray system, Multix Select DR has the same or similar comparable components. It does not affect the indication for use nor the intended use of the device nor does it alter its fundamental scientific technology.
5. Indication for Use:
The Multix Select DR is a digital system used for making X-ray exposures of the head, spinal column, abdomen, thorax (lungs), internal organs and extremities with/without using conventional film/screen and CR -systems, and may be used on pediatric, adult and bariatric patients. The Multix Select DR system is not meant for mammography.
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6. Substantial Equivalence:
- The Multix Select DR is substantially equivalent to the commercially available Siemens Multix Fusion (K121513) radiographic x-ray system with similar indication for use. The Multix Fusion was described in premarket notification K121513 which received FDA Clearance on August 10, 2013. (See Table 1 below).
| Predicate Device | 510(k) | Clearance | Comparable Properties |
|---|---|---|---|
| Name & Manufacturer | Number | Date | |
| Multix FusionSSME | K121513 | 08/10/2012 | Indications for useX-ray tubeCollimatorTableX-ray GeneratorBucky wall standDigital Imaging systemFlat panel detector |
Table 1: Predicate Device Comparable Properties
- Summary of Technological Characteristics of the Subject Device as 7. Compared with the Predicate Device:
The Multix Select DR uses the same Digital Imaging system as the predicate device. The differences in the Subject Device, such as Generator, X-ray Tube, Collimator, radiological table and Bucky Wall Stand, do not affect the safety or effectiveness of the device The Multix Select DR uses a flat panel detector similar to the predicate device, the difference does not affect the safety or effectiveness, which is supported by conforming to detector characteristics described per the FDA Guidance for Submission of 510(k)'s for Solid State X-ray Imaging Devices, (issued on Augus 6, 1999).
| Comparable | Subject Device Multix Select | Predicate Device Multix |
|---|---|---|
| Properties | DR | Fusion |
| Indications for use | The Multix Select DR is adigital system used for makingX-ray exposures of the head,spinal column, abdomen,thorax (lungs), internal organsand extremities with/withoutusing conventional film/screenand CR -systems, and may beused on pediatric, adult andbariatric patients. The MultixSelect DR system is not meantfor mammography. | The Multix Fusion system is aradiographic system used inhospitals, clinics, and medicalpractices, Multix Fusionenables radiographicexposures of the whole bodyincluding: skull,chest, abdomen, andextremities and may be usedon pediatric, adult and bariatricpatients.Exposures may be taken withthe patient sitting, standing, orin the prone position. TheMultix Fusion system is notmeant for mammography. TheMultix Fusion uses a mobile |
Table 2 Subject and Predicate Device Technical Properties
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SIEMENS
Multix Select DR 510(k) K132934 Al Response
| ComparableProperties | Subject Device Multix SelectDR | Predicate Device MultixFusion |
|---|---|---|
| (wired) | ||
| for generating diagnosticimages by converting x-raysinto image signals. The MultixFusion is also designed to beused with conventionalfilm/screen or ComputedRadiography (CR) cassettes. | ||
| X-ray tube | OPTIPHOS 135/30/55R | OPTITOP 150/40/80HC-100 |
| Collimator | Manual | Manual or automatic* (ACSS) |
| Table | Floating table top | Lifting and floating table top |
| X-ray Generator | 55 kW | 55 kW/ 65 kW/ 80 kW |
| Bucky wall stand | Manual vertical movable BuckyWall stand, Non-tiltable BuckyTray. | Manual vertical movableBucky Wall stand, tiltableBucky Tray. |
| Digital Imaging system | Fluorospot Compact High - ResDigital Imaging | Fluorospot Compact High -Res Digital Imaging |
| Flat panel detector | DRZ+ (Gadox) withamorphous silicon (a-Si)technology | Cesium iodide scintillator (Csl)with amorphous silicon (a-Si)technology |
The modifications included in the comparison table above (see Table 2) and described throughout this submission do not alter the Indications for use or fundamental scientific technology of the legally marketed predicate device. The differences between the legally marketed predicate device and the subject device have been assessed via Verification and Validation as well as Risk Management. Any differences in technological characteristics are accompanied by information within this submission that demonstrates the device is as safe and effective as the predicate device and do not raise different questions of safety and effectiveness than the predicate.
8. Performance Testing
Siemens claims conformance to a signed statements of performance standards and Federal X-ray Performance Standards. This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005.
Detector of the Subject Device conforms to the guidance for the submission of 510(k) for Solid State X-ray Imaging Devices. Non-clinical Data is provided in Original 510k submission Appendix G.
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
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EMC Mechanical Safety electrical safety was evaluated according to the IEC Siemens certify to conformance Voluntary Standards Covering Standards. Electrical and Mechanical Safety." (See Table 3 below). In conclusion, the identified risk of EMC/Mechanical/Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness.
Siemens conforms to Voluntary and EPCR standard (see Table 3 below).
Siemens hereby certifies that the subject device the Multix Select DR will be in Clemono neroby ooking recognized consensus standards covering electrical and mechanical safety listed in Table 3 below.
| RecognitionNumber | ProductArea | Title of Standard | Refer. No.&Date | StandardsDev. Org. |
|---|---|---|---|---|
| 5-4 | General | Medical Electrical Equipment - Part 1:General Requirements for Safety, 1988;Amendment 1, 1991-11, Amendment 2, 1995 | 60601-1 | IEC |
| 5-27 | General | Medical Electrical Equipment - Part 1:General Requirements for Safety CollateralStandard: Safety requirements for medicalelectrical system | 60601-1-1:2000 | IEC |
| 5-34 | General | Medical Electrical Equipment - Part 1-2:General Requirements for Safety - Collateralstandard: Electromagnetic Compatibility -Requirements and Tests (Edition 2:2001 withAmendment 1:2004; Edition 2.1 (Edition2:2001 consolidated with Amendment1:2004) | 60601-1-2 | IEC |
| 12-199 | General | Medical Electrical Equipment - Part 1:General requirements for basicsafety3.Collateral Standard: Generalrequirements for Radiation protection indiagnostic X-ray equipment. | 60601-1-3:FirstEd. 1994-07 | IEC |
| 12-210 | Radiology | Medical Electrical Equipment - Part 1-3:General requirements for basic safety andessential performance - Collateral Standard:Radiation protection in diagnostic X-rayequipment | 60601-1-3:Ed.2.0 2008-01 | IEC |
| 5-41 | General | Medical Electrical Equipment - Part 1-4:General requirements for safety - Collateralstandard: Programmable electrical medicalsystems, edition 1.1 | 60601-1-4:2000Consol. Ed. 1.1 | IEC |
| 5-40 | General | Medical devices - application of riskmanagement to medical devices | 14971 Secondedition 2007- | ISO |
Table 3: Conformance to Voluntary Standards
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SIEMENS
Multix Select DR 510(k) K132934 Al Response
| RecognitionNumber | ProductArea | Title of Standard | Refer. No.&Date | StandardsDev. Org. |
|---|---|---|---|---|
| 03-01 | ||||
| 13-8 | Software | Medical device software - Software life cycleprocesses | 62304 Ed. 1.0 | IEC |
| 2-156 | Biocompati-bility | Biological evaluation of medical devices --part 1: evaluation and testing | 10993-1:2009 | AAMI ANSIISO |
| 12-34 | Radiology | Medical electrical equipment - Part 2-7:Particular requirements for the safety of high-voltage generators of diagnostic X-raygenerators | 60601-2-7(1998) | IEC |
| 12-126 | Radiology | Medical electrical equipment -Part 2: Particular requirements for the safetyof X-ray source assemblies and X-ray tubeassemblies for medical diagnosis | 60601-2-28:2010 | IEC |
| 12-127 | Radiology | Medical Electrical Equipment -Part 2: Particular requirements for the safetyof associated equipment of X-ray equipment | 60601-2-32:1994 | IEC |
| 12-238 | Radiology | Digital Imaging and Communications inMedicine | PS 3.1-3.20(2011) | NEMA |
| N/A | Radiology | Medical Electrical Equipment - Part 1-6:General requirements for safety - Collateralstandard: Usability ,First edition, 2004 | 60601-1-6(2004) | IEC |
| 12-201 | Radiology | Medical electrical equipment - Part 2-54:Particular requirements for the basic safetyand essential performance of X-rayequipment for radiography and radioscopy | IEC 60601-2-54(Edition 1.0) | IEC |
Siemens hereby certifies that the subject device the Multix Select DR will meet the applicable requirements of the FDA Performance Standards for lonizing Radiation applicatio roquets for diagnostic X-Ray systems and their major components, as listed Enliting i roduction into interstate commerce. All data will be available for inspection at the firm.
| Table 3 (cont.): Required Performance Standards | ||||
|---|---|---|---|---|
| -- | -- | -- | -------------------------------------------------- | -- |
| 21 CFR Title No. | Title of 21CFR Section |
|---|---|
| 1020.30(c) | Manufacturer's Responsibility (Certification) |
| 1020.30(e) | Identification of X-ray components |
| 1020.30(g) | Information to be provided to assemblers |
| 1020.30(h) | Information to be provided to users |
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KB2934
Page 7 of 7
SIEMENS
Multix Select DR 510(k) K132934 Al Response
| 21 CFR Title No. | Title of 21CFR Section |
|---|---|
| 1020.30(j) | Warning label |
| 1020.30(k) | Leakage Radiation |
| 1020.30(l) | Radiation from components other than the diagnostic sourceassembly |
| 1020.30(m) | Beam Quality |
| 1020.30(n) | Aluminum equivalent of material between patient and imagereceptor |
| 1020.31(a) | Control and indication of technique factors |
| 1020.31(b) | Reproducibility |
| 1020.31(c) | Linearity |
| 1020.31(d) | Field limitation and alignment for mobile, portable and stationarygeneral-purpose x-ray systems |
| 1020.31(e) | Field indication and alignment on stationary general purpose x-ray equipment |
| 1020.31(j) | Beam-on indicators |
General Safety and Effectiveness Concerns: 9.
Instructions for use are included within the device labeling, and the information motions for acc are morage to operate the device in a safe and effective Several safety features including visual and audible warnings are manner. incorporated into the system design. In addition the Multix Select DR is intoliporulou- nio- in error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post processing of X-ray examinations to be responsible for the over and mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Conclusion as to Substantial Equivalence: 10.
The Multix Select DR is intended for the same clinical use as Multix Fusion, and it uses the same or similar components as cleared in Multix Fusion.
The functionality of Multix Select DR is similar to the predicate device. It is Siemens opinion, that the Multix Select DR is substantially equivalent to the cleared predicate device the Multix Fusion (K121513) radiographic x-ray system.
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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in bold and is centered in the image. The text is likely the header of a document or website.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2014
Siemens Medical Solutions, Inc. % Ms. Patricia Jones Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway MALVERN PA 19355
Re: K132934
Trade/Device Name: Multix Select DR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: March 12, 2014 Received: March 13, 2014
Dear Ms. Jones:
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 I hat FDA has made a determination that your device complies with other requirements of the Act that I DA has made a aothernations administered by other Federal agencies. You must Of any I cachi statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CITY rail 807); labornig (21 CFR 803); good manufacturing practice requirements as set device-related adverse overse overse of the contract 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
{8}------------------------------------------------
Page 2-Ms. Jones
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Safetv/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
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
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SIEMENS ______________________________________________________________________________________________________________________________________________________________________
.
. .
:
.
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | |
| Form Approved: OMB No. 0910-0120 | |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K132934 |
| Device Name | Multix Select DR |
| Indications for Use (Describe) | The Multix Select DR is a digital system used for making X-ray exposures of the head, spinal column, abdomen, thorax (lungs), internal organs and extremities with/without using conventional film/screen and CR -systems, and may be used on pediatric, adult and baristric patients. The Multix Select DR system is not meant for mammography. |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14) Page 1 of 1
.
§ 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.