Submission Details
| 510(k) Number | K213497 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2021 |
| Decision Date | November 15, 2021 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Special
ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
Nov 2021
Decision
14d
Days
Class 2
Risk
About This 510(k) Submission
K213497 is an FDA 510(k) clearance for the ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW), a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by H&abyz Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on November 15, 2021, 14 days after receiving the submission on November 1, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.
Device Classification
| Product Code | MQB — Solid State X-ray Imager (flat Panel/digital Imager) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1680 |
Manufacturer
Similar Devices — MQB Solid State X-ray Imager (flat Panel/digital Imager)
All 420
K252911 · Iray Imaging Technology (Haining) Limited
· Oct 2025
K250211 · Innocare Optoelectronics Corp.
· Jul 2025
K250665 · Konica Minolta, Inc.
· Jun 2025
K243734 · Allengers Medical Systems Limited
· Apr 2025
K242770 · DRTECH Corporation
· Mar 2025
K243443 · DRTECH Corporation
· Mar 2025
More from H&abyz Co., Ltd.
View all
K251223
· IZL · Aug 2025
K223930
· MQB · Mar 2023
K203188
· MQB · Mar 2021