(35 days)
Not Found
No
The description focuses on the printing capabilities and connectivity of the device, with no mention of AI or ML for image analysis or processing.
No
The device is a printer that produces hard copy prints of still images from medical imaging systems for patient records and referrals; it does not provide any therapeutic effect.
No
The device is a printer designed to produce hard copies of images for patient records or referrals, not to diagnose medical conditions.
No
The device is described as a "Hybrid Graphic Printer" and the description explicitly mentions "hardware and software testing," indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Sony Hybrid Graphic Printers UT-971AD and UP-991AD are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of these printers clearly states they are used to produce hard copy prints of still images captured by radiology imaging systems (like C-arm, ultrasound, etc.). These are images of the inside of the body, not analyses of bodily fluids or tissues.
- The intended use is for creating hard copies of medical images for patient records or referrals. This is a function related to documentation and communication of imaging results, not the diagnostic testing of biological samples.
- The standards listed (IEC 60601-1, IEC 60601-1-2) are for medical electrical equipment and electromagnetic compatibility, not specifically for IVD devices. While IVD devices are also medical devices and would need to comply with relevant safety standards, these particular standards are not exclusive to IVDs.
In summary, these printers are medical devices used in conjunction with imaging systems, but their function is to print images, not to perform in vitro diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The Sony UP-991AD / UP-971AD Hybrid Graphic Printers are compact, medical grade black and white printers that can accept both analog and digital signal inputs. They are designed to be integrated into radiology imaging systems such as mobile Carm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.
Product codes (comma separated list FDA assigned to the subject device)
LMC
Device Description
The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals.
Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems.
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)
The safety and effectiveness of the proposed UP-991AD and UP-971AD Hybrid Graphic Printers has been confirmed by hardware and software testing. The proposed printers comply with applicable requirements of the following standards:
- IEC 60601-1:2005 + C1:2006 + C2:2007
- AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
- IEC 60601-1-2:2007-03
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUN 2 6 2014
K141346
Page 1 of 7
510(K) SUMMARY FOR THE SONY ELECTRONICS, INC. Sony UP-991AD / UP-971AD Hybrid Graphic Printers
(per 21 CFR 807.92 and http://www.fda.gov/McdicalDevices/DeviceRegulationandGuidant.htm)
1. SUBMITTER/510(K) HOLDER
Sony Electronics Inc. Sony Medical Systems Division l Sony Drive Park Ridge, NJ 07656 Phone: 201-258-4182 Establishment Registration No: 2246606
Brian Zimmer Contact: Contact's Phone: 201-930-6746 Contact's Fax: 201-358-4977 Contact's Email: Brian.zimmer(@am.sony.com
2. DEVICE NAME
| Proprietary Name: | Sony UP-991AD / UP-971AD Hybrid Graphic Printers |
|---|---|
| Common/Usual Name: | Medical Image Hardcopy Device |
| Classification Name: | Camera, Multi Format, Radiological |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Classification Number: | 21 CFR 892.2040 |
| Product Code: | LMC |
3. PREDICATE DEVICES
The following devices are legally marketed devices cleared under K882958 as Sony UP Series Video Printers to which equivalence is being claimed:
- UP-701 Video Graphic Printer .
- UP-811 Video Graphic Printer .
- UP-1000/1100 Color Video Printer t
- . UP-5000 Color Video Printer
4. DEVICE DESCRIPTION
The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such
1
as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals. 1
Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.
5. INDICATIONS FOR USE / INTENDED USE
The Sony UP-991AD / UP-971AD Hybrid Graphic Printers are compact, medical grade black and white printers that can accept both analog and digital signal inputs. They are designed to be integrated into radiology imaging systems such as mobile Carm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient record or for referrals.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE
The proposed UP-991AD and UP-971AD Hybrid Graphic Printers represent a technological upgrade to the predicate Sony UP Series Video Printers. Both the proposed and predicate devices are thermal printers that provide hard copy images captured by connected imaging systems. The proposed UP-991AD and UP-971AD Hybrid Graphic Printers have increased resolution and provide a number of technological features that are not available for the predicate devices - including a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.
Printer control for the predicate devices is provided by a front panel or keypad. The proposed printers have an LCD display panel with a white LED backlight.
May 16, 2014 Sony Electronics Inc., Traditional 510(k) Sony UP-991AD / UP-971AD Hybrid Graphic Printers
I The images printed from the UP-991AD and UP971AD are not to be used for diagnosis.
2
-
- SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
The safety and effectiveness of the proposed UP-991AD and UP-971AD Hybrid Graphic Printers has been confirmed by hardware and software testing. The proposed printers comply with applicable requirements of the following standards:
- SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
-
· IEC 60601-1:2005 + C1:2006 + C2:2007
-
· AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
-
· IEC 60601-1-2:2007-03
8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Not applicable.
9. SUMMARY OF OTHER INFORMATION
Not applicable.
10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS
The indications for use, principles of operation, and technological characteristics of the proposed Sony UP-991AD / UP-971AD Hybrid Graphic Printers are substantially equivalent to the predicate device Sony UP Series Video Printers (subject of K.882958). Differences between the proposed and predicate device are limited to minor differences in technological characteristics. These differences do not impact the safety and effectiveness of the printers for the intended use.
The safety and performance of the Sony UP-991AD / UP-971AD Hybrid Graphic Printers for its intended use are demonstrated by non-clinical testing. Based on the evidence provided. Sony Electronics believes that the proposed Sony UP-991AD / UP-971AD Hybrid Graphic Printer is substantially equivalent to the predicate Sony UP Series Video Printers.
3
| Product
Characteristics | Sony Electronics Inc.
Sony UP-991AD / UP-971AD
Hybrid Graphic Printer | Sony Medical Electronics Co.
Sony UP Series Video Printers (UP-701, UP-811, UP-1000/1100, UP-5000) | | | | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Proposed | UP-701 | UP-811 | UP-1000/1100 | UP-5000 | |
| Regulatory Status
Applications for Use | The Sony UP-991AD / UP-971AD Hybrid Graphic Printers
are compact, medical grade black
and white printers that can accept
both analog and digital signal
inputs. They are designed to be
integrated into radiology imaging
systems such as mobile c-arm,
ultrasound, cardiac
catheterization laboratory and
other compatible medical imaging
systems and produce hard copy
prints of still images captured by
these systems for the patient
record or for referrals. | Sony Video Printers are general purpose devices and are intended for use as accessories for a wide range of electronic
medical diagnostic equipment to provide hard copy images. | | | | |
| Product Code | LMC | | K882958 | | | |
| | | Features | | KQM | | |
| Printing Method | Direct thermal printing | Direct thermal printing | Direct thermal printing | Sublimation heat transfer
printing | Sublimation heat transfer
printing | |
| High Resolution | 325 dpi | 61 dpi | 169 dpi | 101dpi / 132dpi(h/w) | 102dpi/118dpi (h/w) | |
| Gradations | 8 bits (256 levels) processing | 16/32 (black and white) | 64 (black and white) | 64 levels each (yellow, red, blue) | 256 levels each (yellow, magenta, cyan) | |
| Picture Elements | Digital: 7680 x 2560 dots
Video NTSC: 720 x 504 dots
Video PAL: 720 x 604 dots | 235 x 512 dots (NORM),
241 x 512 dots (WIDE): | 472 x 602 dots (NORM),
490 x 640 dots (WIDE) | 466 x 784 PELS | 720 x 468 PELS | |
| Picture Area | DIGITAL:
600 x 200 mm (23 5/8 x 7 7/8 inch) (Max)
VIDEO:
STD NTSC: 182 x 144 mm
PAL: 188 x 140 mm
SIDENTSC: 244 x 184 mm
PAL: 244 x 183 mm | NORM 97 x 133mm(3 7/8 x 5 1/4 inches)
WIDE 100 x 133(3 7/8 x 5 1/4 inches) | NORM 71 x 90mm(2 3/4 x 3 1/2 inches)
WIDE 73 x 96(2 7/8 x 3 3/4 inches) | | 116.5 x 150mm | 116.5 x 155 mm |
| Product
Characteristics | Sony Electronics Inc.
Sony UP-991AD / UP-971AD
Hybrid Graphic Printer | UP-701 | UP-811 | Sony Medical Electronics Co.
Sony UP Series Video Printers (UP-701, UP-811, UP-1000/1100, UP-5000) | UP-1000/1100 | UP-5000 |
| Regulatory Status | Proposed | | | | K882958 | |
| Paper Size | Paper width of 8.25 in. [210 mm] | UPP-110S Paper Roll
Width: 4 3/8 inches
[110mm]
Length: Approx. 6ft 12 3/8 inches [20m] | UPP-110S Paper Roll
Width: 4 3/8 inches
[110mm]
Length: Approx. 6ft 12 3/8 inches [20m] | | UPP-1000 MAVIGRAPH
Printing Paper - 100 sheets
5 3/8 x 8 3/8 inches [140 x 210 mm] | Color: UPC-5010 - 100 sheets
OHP: UPC-5030 - 50 sheets |
| Picture Memory | Digital: 2816 x 7680 x 8 bits
Video: 6 frames (720 x 608 x 8 bits for one frame) | 128K x 4 bits | 448K x 5 bits | | 357K x 6bits | 1024K x 8bits |
| Interface | USB terminal (type A) for USB
flash drive (X1) (UP-991AD
only)
Hi-Speed USB (USB 2.0) (x1)
VIDEO INPUT: BNC type (X1)
NTSC or PAL composite video
signals
1.0Vp-p, 75ohm (NTSC/PAL
automatically discriminated)
VIDEO OUTPUT: BNC type
(x1) Loop-through
REMOTE: Stereo mini jack (x1) | VIDEO INPUT: BNC type
NTSC composite video
signals 1.0Vp-p or 5.0 Vp-
p. 75ohms/high impedance
REMOTE: Stereo mini jack | VIDEO INPUT: BNC type
NTSC composite video
signals 1.0Vp-p or 5.0 Vp-
p, 75ohms/high impedance
MON OUT: BNC type
NTSC composite video
signals 1.0Vp-p. 75 ohms
Loop-through/D/A Output
Changeover Switch Method
REMOTE: Stereo mini jack | | VIDEO INPUT: BNC type
Composite video signals
1.0 +0.6/-0.3 Vp-p, 75
ohms, negative
COMPONENT INPUT:
BNC type R/R-Y, G/Y,
B/B-Y
[R-Y, Y, B-Y
Y 1.0+0.6/-0.3 Vp-p
R-Y, B-Y, 0.7+0.4/-0.2
Vp-p
R,G,B (analog)
0.7+0.4/-0.2 Vp-p
TTL (digital RGB)
TTL level (positive
polarity), 22 kilohms]
SIGNAL INPUT:
SYNC:BNC type,
4.0+1.3/-3.7 Vp-p
(negative polarity) 75
ohms
HD, VD:BNC type,
5.0+3.0/-4.0 Vp-p
(negative polarity), 5
kilohms
MONITOR OUTPUT:
MONITOR: BNC type
[R.G.B 0.7 +-0.1 Vp-p,
75 ohms | VIDEO INPUT: BNC type
NTSC Composite video
signals 1.0 Vp-p, 75 ohms,
negative
COMPONENT INPUT:
[R-Y, B-Y, Y
16 pin connector
Y: 1.0 Vp-p, 75 ohms
R-Y, B-Y: 0.7 Vp-p, 75
ohms
R.G.B VIDEO INPUT:
BNC type, 0.7 Vp-p. 75
ohms
S VIDEO INPUT:
(Separate luminance(Y)
and Chrominance
signals)
Y: 1 Vp-p
C: 0.29 Vp-p
75 ohms
MONITOR OUTPUT:
RGB
25 pin connector
R.G,B: 0.7 Vp-p, 75
ohms
SYNC: 1 Vp-p (negative
polarity), 75 ohms
VIDEO (NTSC composite
video signal) |
| Product
Characteristics | Sony Electronics Inc.
Sony UP-991AD / UP-971AD
Hybrid Graphic Printer | UP-701 | UP-811 | Sony Medical Electronics Co.
Sony UP Series Video Printers (UP-701, UP-811, UP-1000/1100, UP-5000) | UP-1000/1100 | UP-5000 |
| Regulatory Status | Proposed | | | K882958 | SYNC 1.0 +-0.4 Vp-p
(negative polarity) 75
ohms | |
| Power Requirements | AC 100 V to 240 V, 50/60 Hz | AC 100 V to 120 V, 50/60
Hz | AC 100 V to 120 V, 50/60
Hz | AC 120 V, 60 Hz | AC 120 V, 50/60 Hz | AC 120 V, 50/60 Hz |
| Weight | 15lb 7oz [7.0 kg] | 7lb 15oz [3.6 kg] | 8.8lb [4.0 kg] | 102lb 12oz [46.6 kg] | N/A | 33lb 1oz [15.0 kg] |
| Digital Video Input | N/A | N/A | N/A | N/A | N/A | N/A |
| Analog Video Input | Yes | Yes | Yes | Yes | Yes | Yes |
| Multi-picture Mode | Yes - 2, 4, and 6 (Analog) / 2 and
4 (Digital) | N/A | N/A | Yes - 4 | Yes - 4 | Yes - 4, 9 |
| Panoramic Printing | Yes up to a maximum of 600mm
in length | N/A | N/A | N/A | N/A | N/A |
| Printing Speed | Approx. 8 seconds/image (in
standard mode) | 8.5 seconds/screen | 8.8 seconds/screen | Color ribbon: 3 minutes;
Black ribbon: 1 minute | N/A | 1 minute |
| Storage Media | • USB Flash drive (UP-991AD
only) | N/A | N/A | N/A | N/A | N/A |
| Dimensions | 12.5 (W) x 5.25 (H) x 10.5 (D)
inches (D)
[316 (W) x 132.5 (H) x 265 (D)
mm] | 6 1/8 (W) x 6 ½ (H) x 12 ½
(D) inches
[154 (W) x 166 (H) x 318
(D) mm] | 6 1/8 (W) x 6 ½ (H) x 12 ½
(D) inches
[154 (W) x 165 (H) x 318
(D) mm] | 29 3/8 (W) x 12 1/8 (H) x
16 (D) inches
[743 (W) x 307 (H) x 405
(D) mm] | N/A | 16 3/4 (W) x 7 1/2 (H) x 18
3/4 (D) inches
[424 (W) x 190 (H) x 474
(D) mm] |
| LCD Display Panel | Yes | N/A | N/A | N/A | N/A | N/A |
| LED Backlight | Yes | N/A | N/A | N/A | N/A | N/A |
| Function Keys | Front Panel | Front Panel | Front Panel | Operation Panel | Keypad | Keypad |
| Settings Auto Lock | Yes | N/A | N/A | N/A | N/A | N/A |
| Contrast Knob | Yes | N/A | Yes | N/A | N/A | N/A |
| Brightness Knob | Yes | N/A | Yes | Yes | Yes | N/A |
| Automatic Media
Cutter | Yes (UP-991AD only) | N/A | N/A | N/A | N/A | N/A |
| Automatic Detection
of Media Type | Yes (UP-991AD only) | N/A | N/A | N/A | N/A | N/A |
| Print Media | UPT-210BL Blue Thermal
Transparent Film (UP-991AD | UPP-110S | UPP-110S | UPP-1000 | UPC-5010: Color
UPC-5030: OHP | UPC-5010: Color
UPC-5030: OHP |
| Product
Characteristics | Sony Electronics Inc.
Sony UP-991AD / UP-971AD
Hybrid Graphic Printer | UP-701 | UP-811 | Sony Medical Electronics Co.
Sony UP Series Video Printers (UP-701, UP-811, UP-1000/1100, UP-5000)
UP-1000/1100 | UP-5000 | |
| Regulatory Status | Proposed | K882958 | | | | |
| Ribbon | only);
UPP-2010HD, UPP-210SE
Thermal Print Media | N/A | N/A | UPR-1001: Color
UPR-1002: Black | N/A | |
| Foot Switch | N/A | N/A | N/A | N/A | N/A | |
| Remote Control | Optional (FS-24)
Optional (RM-91) | Optional (RM-81) | Optional (RM-81) | N/A | Yes | |
| N/A = Not applicable | | | | | | |
Side-by-Side Comparison of Sony UP-991AD / UP-971AD Hybrid Graphic Printer with Sony UP Series Video Printe
Page 5-4
・
Sony Electronics Inc., Traditional 510(k)
Sony UP-991AD / UP-971AD Hybrid Graphic Printers
May 16, 2014
4
.
May 16, 2014
Sony Electronics Inc., Traditional 510(k)
Sony UP-991AD / UP-971AD Hybrid Graphic Printers
Page 5-5
5
:
:
.
:
Page 5-6
،
May 16, 2014
.
រ
Sony Electronics Inc., Traditional 510(k)
Sony UP-991AD / UP-971AD Hybrid Graphic Printers
6
.
ישו 10
Page 5-7
May 16, 2014
.
Sony Electronics Inc., Traditional 510(k)
Sony UP-991AD / UP-971AD Hybrid Graphic Printers
7
Image /page/7/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three curved lines representing the body and arms. The text "DE" is visible to the right of the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 26, 2014
Sony Electronics, Inc. % Ms. Joanne Bronikowski Senior Regulatory Project Manager Aptiv Solutions, an ICON plc company 62 Forest Street. Suite 300 MARLBOROUGH MA 01752
Re: K141346
Trade/Device Name: Sony Hybrid Graphic Printers (UP-971AD and UP-991AD) Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: May 16, 2014 Received: May 22, 2014
Dear Ms. Bronikowski:
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
8
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
INDICATIONS FOR USE 4.
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)
K141346
Device Name Sony Hybrid Graphic Printer UP-971 AD Sony Hybrid Gruphic Printer UP-991 AD
Indications for Use (Describe)
Sony Hybrid Graphic Printers UT-971AD and UP-991AD are compact, medical grode hlack and white printers that can accept both anslog and digital signal inpus. They are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardine intintion laboratory and other compaible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient rocord or for referrals.
Type of Use (Select one or both. as applicable)
Proscription Use (Part 21 CFR 801 Subpart D)
L. 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)
Smh.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995, 'DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Orug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRASIaM@dda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
FORM FDA 3881 (1/14)
Page 1 of 1
15 11:2" Parland Samse : Pij . All sett
Sony Electronics Inc., Traditional 510(k) May 16, 2014 Sony UP-991AD / UP-971AD Hybrid Graphic Printers
Page 4-1