| Z-0289-2024 | Class II | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiogr | October 2, 2023 |
| Z-0437-2024 | Class II | DRX Revolution Mobile X-Ray System | October 2, 2023 |
| Z-1206-2023 | Class II | DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagno | January 30, 2023 |
| Z-0806-2020 | Class II | Kodak DirectView DR3000/3500 - Product Usage: permanently installed as a diagnostic system intended | January 6, 2020 |
| Z-1207-2019 | Class II | OnSight 3D Extremity System- X-Ray, Tomography Computed System Catalog Numbers: 1743566 (w/ Attach | March 19, 2019 |
| Z-2651-2017 | Class II | DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalo | May 25, 2017 |
| Z-1138-2017 | Class II | Carestream DRX-Revolution Mobile X-Ray System, Model DRXR-1, Catalog No. 1019397 (all other countrie | January 12, 2017 |
| Z-1052-2017 | Class II | Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System | November 21, 2016 |
| Z-2217-2016 | Class II | Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Number 17388 | July 8, 2016 |
| Z-1594-2016 | Class II | CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP | April 15, 2016 |
| Z-1593-2016 | Class II | CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F IMG ST/PO | April 15, 2016 |
| Z-2449-2015 | Class II | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diag | August 7, 2015 |
| Z-1378-2015 | Class II | CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tomographi | January 8, 2015 |
| Z-1377-2015 | Class II | CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or segmen | January 8, 2015 |
| Z-0800-2015 | Class II | DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) | November 25, 2014 |
| Z-0820-2015 | Class II | CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for scre | October 30, 2014 |
| Z-2177-2014 | Class II | Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a permane | July 9, 2014 |
| Z-2143-2014 | Class III | Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestr | July 2, 2014 |
| Z-2142-2014 | Class III | INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream | July 2, 2014 |
| Z-2137-2014 | Class II | KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the U | May 30, 2014 |