Sony Medical Systems
North Attleboro, MA, US
Sony Medical Systems appears in FDA device records in North Attleboro, MA. FDA records list 6 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Sony Medical Systems between 1992 and 2003. The busiest year on record is 1992, with 2. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 1 |
| 1996 | 1 |
| 1997 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K024188 | UP-DF500 FILMSTATION DIGITAL FILM IMAGER | LMC | Substantially Equivalent | |
| K970999 | SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR | JAK | Substantially Equivalent | |
| K961680 | SONY DKR-700 DIGITAL STILL RECORDER | LMB | Substantially Equivalent | |
| K931170 | SONY CARDIAC ANALYSIS AND REVIEW STATION (CARS) | IZI | Substantially Equivalent | |
| K924708 | CINENET CARDIAC IMAGE NETWORK | IZI | Substantially Equivalent | |
| K921275 | SONY LASER VIDEODISC RECORDING SYSTEM | LMB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2771-2015 | Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology. | Tthe medical monitor has either not turned on or has lost image during clinical use. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain