510(k) K253185
- Device
- Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System
- Applicant
- Carestream Health
- 510(k) number
- K253185
- Product code
- IZL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-11
- Date received
- 2025-09-26
- Regulation
- 892.1720
- Classification name
- System, X-Ray, Mobile
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Gina Maiolo
- Address
- 150 Verona St. Rochester NY US 14608 14608
FDA Registration Numbers
- 3005810333
- 3007734888
- 3029916061
- 3011491794
- 3008044777
- 8030233
- 3004977335
- 1418964
- 3011416394
- 3006051164
- 3009001657
- 9617251
- 3015537309
- 3012855798
- 3018269927
- 3002707445
- 3007065358
- 3014209556
- 3010398867
- 3013779985
- 3013679558
- 3015276088
- 1418960
- 3005246977
- 3018077344
- 3033527770
- 3014809646
- 3001722928
- 2126677
- 3007836437
- 3005877899
- 3010300212
- 1225677
- 3013677815
- 3003775006
- 3032116890
- 9610982
- 3011950073
- 3004606964
- 2433615
- 3014403439
- 3011015597
- 3004706313
- 3024891354
- 3008496839
- 3001556265
- 3017375271
- 3009134655
- 3033525986
- 3009077524
- 1219183
- 3003768251
- 9615439
- 1317307
- 3023003446
- 3000126629
- 3021006193
- 3015223550
- 9614430
- 3009715136
- 3008284470
- 3031503890
- 3012127758
- 3015502499
- 3017944270
- 3012624817
- 3023344919
- 3006542593
- 1418484
- 3016674851
- 9613445
- 3025442726
- 3004063527
- 3016250464
- 1222777
- 3006551157
- 9616047
Source Documents
Other 510(k) Records For Product Code IZL
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | 2026-05-14 |
| K253244 | AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) | Poskom Co., Ltd. | 2026-02-23 |
| K250976 | Airbile-100 | Poskom Co., Ltd. | 2025-12-19 |
| K251710 | Mobile X-ray unit (!M1) | Solutions For Tomorrow AB | 2025-10-24 |
| K243864 | BONX805 | Bontech Co., Ltd. | 2025-09-12 |
| K251443 | PROMO | DRGEM Corporation | 2025-08-22 |
| K251223 | HnX-P1, HnX-PB | H&abyz Co., Ltd. | 2025-08-04 |
| K250597 | REMEX Xcam6 | Remedi, Inc. | 2025-07-31 |
| K243473 | PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS | Prognosys Medical Systems Private Limited | 2025-07-29 |
| K250750 | INNOVISION-P5 | Dk Medical Systems Co., Ltd. | 2025-07-18 |
| K244049 | Europa (Alternative: AiRTouch) portable X-ray system | Livermoretech, Inc. | 2025-05-28 |
| K241980 | !M1 | Solutions For Tomorrow AB | 2025-05-06 |
| K241996 | ULTRA 1040 | Ecoray Co., Ltd. | 2025-04-18 |
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | 2024-12-16 |
| K241505 | DRX-Revolution Mobile X-ray System | Carestream Health, Inc. | 2024-12-10 |