SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD

K141454 · Sony Electronics, Inc. · LMC · Jun 26, 2014 · Radiology

Device Facts

• Record ID: K141454
• Device Name: SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
• Applicant: Sony Electronics, Inc.
• Product Code: LMC · Radiology
• Decision Date: Jun 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended Use

The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-X898MD (Hybrid) Graphic Printer can accept both analog and digital signal inputs. Both models are designed to be integrated into digital 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.

Device Story

Compact, medical-grade black and white thermal printers; integrate into radiology imaging systems (mobile c-arm, ultrasound, cardiac cath lab). UP-D898MD accepts digital inputs; UP-X898MD accepts analog and digital inputs. Device transforms captured still images into 325 dpi hard copy prints. Operated by clinical staff in medical environments. UP-X898MD includes USB flash drive storage. Output used for patient records or referrals; not for diagnostic purposes. Features include LCD display with LED backlight, faster printing, and menu joystick for setting control. Benefits include efficient documentation of medical images.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical performance testing, including hardware and software verification and compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1, AAMI/ANSI ES 60601-1, IEC 60601-1-2).

Technological Characteristics

Direct thermal printing; 325 dpi resolution; 256 gradations. Dimensions: 154 x 88 x 240 mm. Connectivity: Digital (USB) and Analog (BNC) inputs. Features: LCD display with LED backlight, menu joystick, USB flash drive storage (UP-X898MD). Power: 100-240V AC. Standards: IEC 60601-1, AAMI/ANSI ES 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for use as an accessory to medical imaging systems (e.g., mobile c-arm, ultrasound, cardiac cath lab) to produce hard copy prints of still images for patient records or referrals. Not for diagnostic use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sony Video Graphic Printer UP-850 (K890826)

Submission Summary (Full Text)

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# IUN 2 6 2014

K 141454
Page 1 of 6

# 510(K) SUMMARY FOR THE SONY ELECTRONICS, INC. Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers (per 21 CFR 807.92 and http://www.fda.gov/MedicalDeviceRegulationandGuidance/default.htm)

# 1. SUBMITTER/510(K) HOLDER

Sony Electronics Inc. Sony Medical Systems Division 1 Sony Drive Park Ridge, NJ 07656 Phone: [phone] Establishment Registration No: 2246606

Contact: Brian Zimmer Contact's Phone: [phone] Contact's Fax: [phone] Contact's Email: [e-mail]

## 2. DEVICE NAME

UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Proprietary Name: 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 DEVICE

The proposed Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are substantially equivalent to the Sony Video Graphic Printer UP-850, cleared under K890826.

## 4. DEVICE DESCRIPTION

The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD only accepts digital signal inputs and the UP-X898MD accepts both analog and digital signal inputs.

The printers are designed to be integrated into radiology imaging systems such as

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mobile c-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems and produce 325 dpi high resolution hard copy prints of still images captured by these systems for the patient record purposes or referrals. The images cannot be utilized for diagnostic purposes. Additionally, the UP-X898MD (Hybrid) Printer can store images on a connected USB flash drive.

## 5. INDICATIONS FOR USE / INTENDED USE

The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers are compact, medical grade black and white printers. The UP-D898MD (Digital) only accepts digital signal inputs and the UP-X898MD (Hybrid) accepts both analog and digital signal inputs. Both printers are designed to be integrated into digital 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.

Like the proposed device, the predicate Sony Video Graphic Printer UP-850 are medical grade black and white printers, indicated for use with a wide range of electronic medical diagnostic equipment. The predicate printers were indicated for use with ultrasound and radiological imaging systems and surgical camera systems as well as any other systems that generate the specified video signal output.

#### 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

The proposed Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Printers represent a technological upgrade to the predicate Sony UP-850 Video Graphic Printer. Both the proposed and predicate devices are thermal printers that provide hard copy images captured by connected imaging systems. The proposed UP-D898MD and UP-X898MD Printers have increased resolution and provide a number of technological features that are an improvement from the predicate devices - including an LCD display panel with LED backlight for controlling settings easily, faster printing speed, and ability to accept digital video input.

## 7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

The safety and effectiveness of the proposed UP-D898MD and UP-X898MD Graphic Printers have been confirmed by hardware and software testing. The proposed printers comply with applicable requirements of the following standards:

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- · IEC 60601-1:2005 + C1:2006 + C2:2007
- AAMI/ANSI ES 60601-1: 2005 + C1:2009 + A2:2010
- IEC 60601-1-2:2007

### 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-X898MD (Digital) / UP-D898MD (Hybrid) Graphic Printers are substantially equivalent to the predicate Sony Video Graphic Printer UP-850 (subject of K890826). Differences between the proposed device and the Sony Video Graphic Printer UP-850 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-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printer for its intended use is demonstrated by non-clinical testing. Based on the evidence provided, Sony Electronics believes that the proposed Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are substantially equivalent to the predicate Sony Video Graphic Printer UP-850.

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| | Sony Electronics Inc.<br>Sony UP-X898MD / UP-D898MD Graphic Printers | Sony Electronics Inc.<br>Sony Video Graphic Printer UP-850 |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Characteristics<br>Regulatory Status<br>Product Code<br>Indications for Use | Proposed | |
| | LMC | K890826<br>KQM |
| | The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-X898MD (Hybrid) Graphic Printer can accept both analog and digital signal inputs. Both models are designed to be integrated into digital 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. | The Sony Video Printers UP Series is a general purpose device and is intended for use as an accessory for a wide range of electronic medical diagnostic equipment to provide hard copy images. This equipment includes ultrasound and radiological imaging systems and surgical camera systems as well as any other systems that generate the specified video signal output. |
| | Features | |
| Printing Method<br>High Resolution | Direct thermal printing<br>325 dpi | Direct thermal printing<br>325 dpi |
| Gradations | 256 levels | 128 levels |
| Picture Elements | UP-X898MD:<br>• Digital: 4096 x 1280 dots<br>• Video NTSC: 720 x 504 dots<br>• Video PAL: 720 x 604 dots<br><br>UP-D898MD:<br>• Digital: 4096 x 1280 dots | NORM: 472 lines x 700 dots (EIA), 560 lines x 700 dots (CCIR)<br><br>WIDEI: 490 lines x 736 dots (EIA), 582 lines x 736 dots (CCIR)<br><br>WIDE2: 508 lines x 768 dots (EIA), 608 lines x 768 dots (CCIR) |
| Picture Area | UP-X898MD:<br>Digital: 320 x 100 mm (12 5/8 x 3 7/8 inch) (Max)<br>STD Video NTSC: 94 x 73 mm<br>Video PAL: 94 x 71 mm (WIDEI)<br>SIDE Video-NTSC: 124 x 96 mm, Video-PAL: 127 x 96 mm (WIDEI) | NORM: 70 x 91 mm (2 2/4 x 3 37/64 inch) (EIA and CCIR)<br><br>WIDE1: 73 x 96 mm (2 7/8 x 3 25/32) (EIA and CCIR)<br><br>WIDE2: 75 x 100mm (2 61/64 x 3 15/16 inch) (EIA and CCIR) |
| Paper Size | UP-D898MD:<br>320 x 100 mm (12 5/8 x 4 inch)<br>110mm (4 3/8 inch) | 110mm (4 3/8 inch) |
| Picture Memory | UP-X898MD:<br>Digital: 4096 x 1280 x 8 bits<br>Video: 10 frame memories (850 k x 8 bits per frame) | |
| Product<br>Characteristics | Sony Electronics Inc.<br>Sony UP-X898MD / UP-D898MD Graphic Printers | Sony Electronics Inc.<br>Sony Video Graphic Printer UP-850 |
| Regulatory Status | Proposed | K890826 |
| Product Code | LMC | KQM |
| Interface | UP-D898MD:<br>Digital: 4,096 x 1,280 x 8 (bit)<br>UP-X898MD:<br>USB connector (Type A) USB connector (Type A) lamp USB connector (Type B) | Input connector: VIDEO INPUT (BNC type) EIA or CCIR<br>composite video signals, 1.0 Vp-p, 75Ω high-impedance<br>Output connector: MONITOR OUT (BNC type), EIA or CCIR,<br>Composite video signals, 1.0 Vp-p, 75 Ω, loop-through/ D/A<br>output changeover switch method<br>DIP Switches<br>REMOTE Commander: stereo mini jack |
| | Input connector: VIDEO INPUT (BNC type) NTSC or PAL composite<br>video signals, Vp-p, 75 Ω (NTSC or PAL automatically discriminated)<br>Output connector: VIDEO OUT (BNC type) Loop-through<br>REMOTE Commander: stereo mini jack | |
| Power Requirements | UP-D898MD:<br>USB connector<br>AC 100 V to 240 V, 50/60Hz | AC 100 V to 240 V, 50/60Hz |
| Weight | 5lb 8oz (2.5 kg) | 8lb 10oz (3.9 kg) |
| Digital Video Input | Yes (UP-D898MD and UP-X898MD) | No |
| Analog Video Input | Yes (UP-X898MD only) | Yes |
| Multi-picture Mode | Yes | No |
| Printing Speed | UP-X898MD:<br>Approx. 1.9 seconds/image (at standard setting)<br>Normal speed mode: Approx. 3.3 seconds/image (at standard setting) | 9 seconds per image (at aspect ratio 3:4) |
| | UP-D898MD:<br>Approx. 1.9 seconds/image (960 x 1,280 dots)<br>Normal speed mode: Approx. 3.3 seconds/image (960 x 1,280 dots) | |
| Storage Media | USB Flash drive (UP-X898MD only) | No |
| Dimensions | 6 1/16 (W) x 3 ½ (H) x 9 ½ (D) inches<br>[154 (W) x 88 (H) x 240 (D) mm] | 6 1/16 (W) x 6 ½ (H) x 12 43/64 (D) inches<br>[154 (W) x 165 (H) x 322 (D) mm] |
| LCD Display Panel | Yes | No |
| LED Backlight | Yes | No |
| Function Keys | Front Panel | Front Panel |
| Settings Auto Lock | Yes | No |
| Contrast Knob | Yes | Yes |
| Brightness Knob | Yes | Yes |
| Volume Knob | Yes | No |
| Product<br>Characteristics | Sony UP-X898MD / UP-D898MD Graphic Printers<br>Sony Electronics Inc. | Sony Video Graphic Printer UP-850<br>Sony Electronics Inc. |
| Regulatory Status | Proposed | K890826 |
| Product Code | LMC | KQM |
| Menu Lever (Joystick) | Yes | No |
| Paper Cutter | Yes | Yes |
| Print Media | Type I: UPP-110S High Quality Printing Paper;<br>Type II: UPP-110HD High Density Printing Paper; and<br>Type V: UPP-110HG High Glossy Printing Paper | Type I: UPP-110S High Quality Printing Paper<br>Type I: UPP-110 High Quality Printing Paper<br>Type II: UPP-110HD High Density Printing Paper |
| Foot Switch | Optional (FS-24) | Optional (FS-20) |
| Remote Control | Optional (RM-91) | Optional (RM-81) |

de-by-Side Comparison of Sony UP-X898MD / UP-D898MD Graphic Printers with Sony Video Graphic Printer UP-8

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Sony Electronics Inc., Traditional 510(k)
Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printer

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May 30, 2014 Sony Electronics Inc., Traditional 510(k)
Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) (Hybrid) Graphic Printer

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

#### Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Public Health Service

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: K141454

Trade/Device Name: Sony Digital Printer UP-D898MD/Sony Hybrid Printer UP-X898MD Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: May 30, 2014 Received: June 2, 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.

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Page 2-Ms. Bronikowski

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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

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#### INDICATIONS FOR USE 4.

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | |

KH1454 Device Name

Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Grephic Printers

#### Indications for Use (Describe)

The Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers are compact, medical grade black and white digital printers. The Sony UP-D898MD (Digital) Graphic Printer accepts only digital signal inputs. The Sony UP-NYRMA (Hytrid) Granhic Printer can accept hath analog and digital signal inguts. Thath models are deaigned to be integrated into digital radiology imaging such as mobile c-arm. Ultrasound, cardiac cathelerization laboratory and other compatible medical imaging systems and produce hard copy prints of still images captured by the patient record or for referrais.

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)

#### 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)

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BILL OF SALE

May 30, 2014 Sony Electronics Inc., Traditional 510(k) Sony UP-D898MD (Digital) / UP-X898MD (Hybrid) Graphic Printers

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