Who is the manufacturer of SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD?

Sony Electronics, Inc. filed the 510(k) submission for SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD (K141346).

What is the FDA product code for SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD?

LMC. It is classified under 21 CFR 892.2040 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD?

UP-701 Video Graphic Printer (K882958); UP-811 Video Graphic Printer (K882958); UP-1000/1100 Color Video Printer (K882958); UP-5000 Color Video Printer (K882958).

Who can help prepare an FDA 510(k) submission like SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD

K141346 · Sony Electronics, Inc. · LMC · Jun 26, 2014 · Radiology

Device Facts

Record ID	K141346
Device Name	SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
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-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.

Device Story

Compact black and white thermal printers; accept analog and digital signal inputs from radiology imaging systems (mobile C-arm, ultrasound, cardiac cath lab). Transform captured still images into 325 dpi high-resolution hard copies on paper or transparent blue film (UP-991AD only). Operated by clinicians in clinical settings. Features include multi-picture print mode, panoramic printing, and LCD display. UP-991AD includes USB flash drive storage, automatic media detection, and integrated media cutter. Output used as reference prints for patient records or referrals; not for diagnostic purposes.

Clinical Evidence

No clinical data. Safety and effectiveness confirmed by hardware and software bench testing, including compliance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Direct thermal printing; 325 dpi resolution; 8-bit (256 levels) processing. Inputs: Analog (BNC, NTSC/PAL) and Digital (USB). Features: LCD display with white LED backlight, automatic media detection, integrated media cutter (UP-991AD). Power: 100-240V AC. Connectivity: USB 2.0, BNC video I/O. Standards: IEC 60601-1, AAMI/ANSI ES 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for use with radiology 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

UP-701 Video Graphic Printer (K882958)
UP-811 Video Graphic Printer (K882958)
UP-1000/1100 Color Video Printer (K882958)
UP-5000 Color Video Printer (K882958)

Related Devices

K141454 — SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD · Sony Electronics, Inc. · Jun 26, 2014
K024188 — UP-DF500 FILMSTATION DIGITAL FILM IMAGER · Sony Medical Systems · Feb 4, 2003
K083522 — SONY UP-DF750 DIGITAL FILM IMAGER · Sony Electronics, Inc. · Jan 9, 2009
K971973 — KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER · Eastman Kodak Company · Aug 25, 1997
K032635 — DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300 · Agfa Corp. · Sep 24, 2003

Submission Summary (Full Text)

{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}------------------------------------------------ - 7. 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: - · 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…