The following data is part of a premarket notification filed by Assemblecircle Corp. with the FDA for Webceph.
| Device ID | K220903 |
| 510k Number | K220903 |
| Device Name: | WebCeph |
| Classification | System, Image Processing, Radiological |
| Applicant | AssembleCircle Corp. R02-ho 8th Floor, 12, Daewangpangyo-ro 645beon-gil Bundang-gu Seongnam-si, KR 13487 |
| Contact | Jang Hoon Kim |
| Correspondent | Edward Park LightenBridge LLC 4408 Tortuga Ln McKinney, TX 75070 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800183400008 | K220903 | 000 |