The following data is part of a premarket notification filed by Careray Digital Medical System Co., Ltd. with the FDA for Careview 1800r.
| Device ID | K141488 |
| 510k Number | K141488 |
| Device Name: | CAREVIEW 1800R |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. 3001 WINCHESTER BLVD, STE 3 Campbell, CA 95008 |
| Contact | Jamie Ku |
| Correspondent | Jamie Ku CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. 3001 WINCHESTER BLVD, STE 3 Campbell, CA 95008 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-05 |
| Decision Date | 2015-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970597830219 | K141488 | 000 |