The following data is part of a premarket notification filed by Drtech Corp. with the FDA for Flaatz 600 Series (flaatz 600/601).
| Device ID | K132842 |
| 510k Number | K132842 |
| Device Name: | FLAATZ 600 SERIES (FLAATZ 600/601) |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | DRTECH CORP. 333-1, SANGDAEWON1-DONG JUNGWON-GU Seongnam-shi, Gyeonggi-do, KR 462-807 |
| Contact | Choul-woo Shin |
| Correspondent | Choul-woo Shin DRTECH CORP. 333-1, SANGDAEWON1-DONG JUNGWON-GU Seongnam-shi, Gyeonggi-do, KR 462-807 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-10 |
| Decision Date | 2014-02-21 |
| Summary: | summary |