The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Star-x, Intraoral X-ray System.
| Device ID | K190357 |
| 510k Number | K190357 |
| Device Name: | Star-X, Intraoral X-ray System |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | HDX WILL Corp. #105,106,201,202,203,204,38,Osongsaengmyeong-4-ro Osong-eup,Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Myoung-joon Lee |
| Correspondent | Myoung-joon Lee HDX WILL Corp. #105,106,201,202,203,204,38,Osongsaengmyeong-4-ro Osong-eup,Heungdeok-gu Cheongju-si, KR 28161 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-15 |
| Decision Date | 2019-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800005200151 | K190357 | 000 |