AIRO Computed Tomography (CT) X-ray System
FDA 510(k) clearance K180393 · decided 2018-03-15
Clearance details
- K-number
- K180393
- Device name
- AIRO Computed Tomography (CT) X-ray System
- Applicant
- Mobius Imaging, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-02-13
- Decision date
- 2018-03-15
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shirley, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mobius Imaging
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 |
|---|---|---|
| BodyTom Elite (NL4000) (K253450) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| CardIQ Suite (K253770) | GE Medical Systems SCS | 2026-07-21 |
| Enhanced Boundary for PCCT (K253560) | Ge Medical Systems, LLC | 2026-06-24 |
| Respiratory Gating for Scanners (2.1) (K253026) | Varian Medical Systems, Inc. | 2026-06-04 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| Spectral CT Verida Family (K253649) | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| True Definition DL (K253686) | Ge Healthcare Japan Corporation | 2026-03-23 |
| CT Rembra RT; CT Areta RT; CT Rembra (K252992) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| Photonova Spectra, Photonova Spectra Select (K253520) | Ge Medical Systems, LLC | 2026-03-20 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Extremity CT Imaging System (K252249) | Mars Bioimaging , Ltd. | 2026-03-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray Syst recall (Z-1040-2026) | Mobius Imaging, LLC | 2026-01-09 |
| Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray Syst recall (Z-1041-2026) | Mobius Imaging, LLC | 2026-01-09 |
| MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. recall (Z-0957-2023) | Mobius Imaging, LLC | 2023-01-17 |
| MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) syst recall (Z-0344-2023) | Mobius Imaging, LLC | 2022-12-06 |