Sony Medical Systems
Country not established
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sony Medical Systems makes
Sony Medical Systems manufactures medical imaging and display devices, including digital film imagers for processing radiographic images, digital still recorders for capturing and storing medical images, and color graphic monitors for cardiac imaging. Their portfolio also includes network solutions for cardiac imaging, such as the CINENET Cardiac Image Network, and systems for recording and reviewing medical data, like the Cardiac Analysis and Review Station (CARS). Additional offerings include laser videodisc recording systems for archiving and playback of medical visual content.
The company’s devices are classified under FDA categories Class I and Class II, with regulatory submissions recorded in the FDA’s 510(k) database. Their products are listed in the United States, where the manufacturer is based.
Catalogue
Cinenet Cardiac Image Network Ref K924708
Regimes: 510(k) Registry: 510(k)Up-DF500 Filmstation Digital Film Imager Ref K024188
Regimes: 510(k) Registry: 510(k)Sony Pgm-100P1MD Trinitron Color Graphic Monitor Ref K970999
Regimes: 510(k) Registry: 510(k)Sony Dkr-700 Digital Still Recorder Ref K961680
Regimes: 510(k) Registry: 510(k)Sony Cardiac Analysis And Review Station (Cars) Ref K931170
Regimes: 510(k) Registry: 510(k)Sony Laser Videodisc Recording System Ref K921275
Regimes: 510(k) Registry: 510(k)
FDA recalls
2015
- 13 Jan 2015 Z-2771-2015 Class II Terminated Tthe medical monitor has either not turned on or has lost image during clinical use.
Full distribution text
- 13 Jan 2015 Z-2771-2015 Class II Terminated Tthe medical monitor has either not turned on or has lost image during clinical use.
Frequently asked questions
How many devices does Sony Medical Systems have in the registry?
The registry currently lists 6 devices for Sony Medical Systems. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sony Medical Systems's devices?
Among its 6 most recently registered devices, Sony Medical Systems has devices listed in FDA 510(k) (6 devices).
What risk classes do Sony Medical Systems's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sony Medical Systems's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sony Medical Systems?
FDA recall records list 1 recall initiated by Sony Medical Systems, the most recent initiated on 13 Jan 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sony Medical Systems in the registry?
The most recently registered devices listed for Sony Medical Systems include CINENET CARDIAC IMAGE NETWORK, UP-DF500 FILMSTATION DIGITAL FILM IMAGER, SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR and SONY DKR-700 DIGITAL STILL RECORDER.