DX-D 100
FDA 510(k) clearance K103597 · decided 2011-01-03
Clearance details
- K-number
- K103597
- Device name
- DX-D 100
- Applicant
- Agfa Healthcare N.V.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-08
- Decision date
- 2011-01-03
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- IZL
- Device class
- 2
- Regulation number
- 892.1720
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Greenville, SC, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Agfa Healthcare N.V.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| XLITE (K260236) | GEMSS HEALTHCARE CO., LTD. | 2026-08-03 |
| Portable DR Imaging System (K253058) | Shantou Institute of Ultrasonic Instruments Co., Ltd. | 2026-06-18 |
| RAYMO Mobile X-ray System (Model: RAYMO) (K260085) | DRGEM Corporation | 2026-05-14 |
| Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (K253185) | Carestream Health | 2026-03-11 |
| AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (K253244) | Poskom Co., Ltd. | 2026-02-23 |
| Airbile-100 (K250976) | Poskom Co., Ltd. | 2025-12-19 |
| Mobile X-ray unit (!M1) (K251710) | Solutions For Tomorrow AB | 2025-10-24 |
| BONX805 (K243864) | Bontech Co., Ltd. | 2025-09-12 |
| PROMO (K251443) | DRGEM Corporation | 2025-08-22 |
| HnX-P1, HnX-PB (K251223) | H&abyz Co., Ltd. | 2025-08-04 |
| REMEX Xcam6 (K250597) | Remedi, Inc. | 2025-07-31 |
| PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (K243473) | Prognosys Medical Systems Private Limited | 2025-07-29 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, con recall (Z-1462-2024) | Agfa N.V. | 2024-04-02 |
| AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing di recall (Z-1698-2017) | AGFA Healthcare Corp. | 2017-03-29 |
| AGFA DX-D 100 is a mobile digital radiography x-ray system recall (Z-1745-2015) | AGFA Healthcare Corp. | 2015-06-10 |
| Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in prov recall (Z-2176-2014) | AGFA Healthcare Corp. | 2014-08-10 |
| AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in pro recall (Z-2081-2014) | AGFA Corp. | 2014-07-21 |
| AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in pro recall (Z-1487-2013) | AGFA Corp. | 2013-06-06 |