(204 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard X-ray system components.
No.
The device is described as a "digital system used for making X-ray exposures" for diagnosis, not for treating conditions.
Yes
The device is an X-ray system used to create images of various anatomical sites. These images are then used by healthcare professionals to determine the presence or nature of a disease or condition, which is a diagnostic purpose.
No
The device description explicitly lists hardware components such as a radiologic table, x-ray generator, x-ray tube, flat panel detector, imaging system, and Bucky-wall stand. This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for making X-ray exposures of various parts of the body. This is an in vivo diagnostic procedure, meaning it is performed on a living organism (the patient).
- Device Description: The description details components like an X-ray generator, X-ray tube, flat panel detector, patient table, and wall stand. These are all components of an X-ray imaging system used for capturing images of the inside of the body.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions. This device does not perform such tests.
The Multix Select DR is a medical imaging device used for diagnostic purposes, but it falls under the category of in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications 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.
Product codes
90 KPR
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head, spinal column, abdomen, thorax (lungs), internal organs and extremities
Indicated Patient Age Range
pediatric, adult and bariatric patients
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)
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.
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.
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
§ 892.1680 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
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
1
-
- 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.
2
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 Fusion | |||
| SSME | K121513 | 08/10/2012 | Indications for use |
| X-ray tube | |||
| Collimator | |||
| Table | |||
| X-ray Generator | |||
| Bucky wall stand | |||
| Digital Imaging system | |||
| Flat 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 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. | The Multix Fusion system is a | |
| radiographic system used in | ||
| hospitals, clinics, and medical | ||
| practices, Multix Fusion | ||
| enables radiographic | ||
| exposures of the whole body | ||
| including: skull, | ||
| chest, abdomen, and | ||
| extremities and may be used | ||
| on pediatric, adult and bariatric | ||
| patients. | ||
| Exposures may be taken with | ||
| the patient sitting, standing, or | ||
| in the prone position. The | ||
| Multix Fusion system is not | ||
| meant for mammography. The | ||
| Multix Fusion uses a mobile |
Table 2 Subject and Predicate Device Technical Properties
3
SIEMENS
Multix Select DR 510(k) K132934 Al Response
| Comparable
Properties | Subject Device Multix Select
DR | Predicate Device Multix
Fusion |
|--------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (wired) |
| | | for generating diagnostic
images by converting x-rays
into image signals. The Multix
Fusion is also designed to be
used with conventional
film/screen or Computed
Radiography (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 Bucky
Wall stand, Non-tiltable Bucky
Tray. | Manual vertical movable
Bucky Wall stand, tiltable
Bucky Tray. |
| Digital Imaging system | Fluorospot Compact High - Res
Digital Imaging | Fluorospot Compact High -
Res Digital Imaging |
| Flat panel detector | DRZ+ (Gadox) with
amorphous 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.
4
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.
| Recognition
Number | Product
Area | Title of Standard | Refer. No.&
Date | Standards
Dev. 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 Collateral
Standard: Safety requirements for medical
electrical system | 60601-1-1:
2000 | IEC |
| 5-34 | General | Medical Electrical Equipment - Part 1-2:
General Requirements for Safety - Collateral
standard: Electromagnetic Compatibility -
Requirements and Tests (Edition 2:2001 with
Amendment 1:2004; Edition 2.1 (Edition
2:2001 consolidated with Amendment
1:2004) | 60601-1-2 | IEC |
| 12-199 | General | Medical Electrical Equipment - Part 1:
General requirements for basic
safety3.Collateral Standard: General
requirements for Radiation protection in
diagnostic X-ray equipment. | 60601-1-3:First
Ed. 1994-07 | IEC |
| 12-210 | Radiology | Medical Electrical Equipment - Part 1-3:
General requirements for basic safety and
essential performance - Collateral Standard:
Radiation protection in diagnostic X-ray
equipment | 60601-1-3:Ed.
2.0 2008-01 | IEC |
| 5-41 | General | Medical Electrical Equipment - Part 1-4:
General requirements for safety - Collateral
standard: Programmable electrical medical
systems, edition 1.1 | 60601-1-4:2000
Consol. Ed. 1.1 | IEC |
| 5-40 | General | Medical devices - application of risk
management to medical devices | 14971 Second
edition 2007- | ISO |
Table 3: Conformance to Voluntary Standards
5
SIEMENS
Multix Select DR 510(k) K132934 Al Response
| Recognition
Number | Product
Area | Title of Standard | Refer. No.&
Date | Standards
Dev. Org. |
|-----------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|------------------------|
| | | | 03-01 | |
| 13-8 | Software | Medical device software - Software life cycle
processes | 62304 Ed. 1.0 | IEC |
| 2-156 | Biocompati-
bility | Biological evaluation of medical devices --
part 1: evaluation and testing | 10993-1:2009 | AAMI ANSI
ISO |
| 12-34 | Radiology | Medical electrical equipment - Part 2-7:
Particular requirements for the safety of high-
voltage generators of diagnostic X-ray
generators | 60601-2-7
(1998) | IEC |
| 12-126 | Radiology | Medical electrical equipment -
Part 2: Particular requirements for the safety
of X-ray source assemblies and X-ray tube
assemblies for medical diagnosis | 60601-2-28:
2010 | IEC |
| 12-127 | Radiology | Medical Electrical Equipment -
Part 2: Particular requirements for the safety
of associated equipment of X-ray equipment | 60601-2-32:
1994 | IEC |
| 12-238 | Radiology | Digital Imaging and Communications in
Medicine | PS 3.1-3.20
(2011) | NEMA |
| N/A | Radiology | Medical Electrical Equipment - Part 1-6:
General requirements for safety - Collateral
standard: Usability ,First edition, 2004 | 60601-1-6
(2004) | IEC |
| 12-201 | Radiology | Medical electrical equipment - Part 2-54:
Particular requirements for the basic safety
and essential performance of X-ray
equipment 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 |
6
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 source |
| assembly | |
| 1020.30(m) | Beam Quality |
| 1020.30(n) | Aluminum equivalent of material between patient and image |
| receptor | |
| 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 stationary |
| general-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.
7
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
9
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (1/14) Page 1 of 1
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