HealthCCSng
Nano-X AI , Ltd.
Nano-X AI Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012453401 | 3012453401 | Nano-X AI Ltd. | 1 | N | 2026-01-01 | Shlomo Shmeltzer Road 94 PO BOX 3486 ISRAEL Petah Tikva Central IL 4970602 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 187762 | 1149147054 | K241440 | HealthCCSng | JAK | 2024-08-19 |
| 187762 | 1649490499 | K233080 | HealthFLD | JAK | 2024-02-08 |
| 187762 | 1043812886 | K213944 | HealthOST | JAK | 2022-04-22 |
| 187762 | 1716865905 | K211803 | HealthPPT | QFM | 2021-12-15 |
| 187762 | 1134471683 | K210085 | HealthCCSng | JAK | 2021-09-15 |
| 187762 | 1081669724 | K192320 | HealthCXR | QFM | 2019-11-26 |
| 187762 | 1366791628 | K190424 | HealthICH | QAS | 2019-06-13 |
| 187762 | 1990138130 | K190362 | HealthPNX | QFM | 2019-05-06 |
| 187762 | 1490608238 | K172983 | HealthCCS | JAK | 2018-06-13 |
| 187762 | 1209506125 |
Product Codes Associated With Registrations#
PMN#
HealthFLD
Nano-X AI , Ltd.
GUDID#
HealthOST - 1.2
2025-12-14
HealthCCSng - -
2025-02-19
HealthCCSng - 2.0
2024-11-21
HealthFLD - 1.0
2024-11-21
HealthCCS - 3.0.0
2019-04-04
HealthPNX - 1.0.6
2019-05-12
HealthICH - 2.0.5
2019-07-02
HealthICH - 2.1.3
2020-01-01
HealthCXR - 1.0.0
2020-01-03
HealthICH - 3.0.0
2020-03-06
HealthVCF - 1.0
2020-09-21
HealthMammo - 2.2
2020-09-21
HealthCCSng - 1.0
2021-10-18
HealthPPT - 1.0
2021-12-30
HealthPNX - 2.0.0
2020-06-12
HealthOST - 1.1
2022-08-01
HealthCCSng - 1.1
2023-05-04
HealthOST - 1.1
2023-05-09