The following data is part of a premarket notification filed by Samsung Electronics Co., Ltd. with the FDA for Gr40cw.
| Device ID | K153401 |
| 510k Number | K153401 |
| Device Name: | GR40CW |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, KR 443-742 |
| Contact | Chulsin Kim |
| Correspondent | Chulsin Kim SAMSUNG ELECTRONICS CO., LTD. 129, SAMSUNG-RO YEONGTONG-GU Suwon-si, KR 443-742 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-24 |
| Decision Date | 2015-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08801643431419 | K153401 | 000 |