CTXX85
FDA 510(k) K182147 · Analogic Corporation
510(k) numberK182147
Submission
- Device name
- CTXX85
- Applicant
- Analogic Corporation
Peabody, MA, US - Received
- August 8, 2018
- Decision date
- September 7, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K201231 | CTxx85 CT ScannerJAK · Traditional | 02/02/2021SE |
| K172058 | CT6485, CT12885JAK · Traditional | 02/13/2018SE |
| K161342 | Sonic WindowIYO · Special | 06/15/2016SE |
| K140126 | Sonic WindowIYO · Abbreviated | 03/04/2014SE |
| K071430 | Synerad Omni, Models AN6255 and AN6265KPR · Special | 06/21/2007SE |
| K070829 | Synepix 4600 DetectorMQB · Abbreviated | 05/09/2007SE |
| K051903 | Fetalgard Lite-Nibp, Model Fgl-NibpDXN · Traditional | 12/27/2005SE |
| K052447 | Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600JAK · Abbreviated | 09/21/2005SE |
| K050919 | Lifegard II Family Multi-Function Patient Monitor, Models AN4320, AN4320P, AN4321P…DSI · Abbreviated | 06/14/2005SE |
| K043025 | Synerad Omni, Digital X-Ray System, Model AN6250KPR · Abbreviated | 11/19/2004SE |
Questions and answers
When was CTXX85 cleared by the FDA?
CTXX85 (K182147) received a 510(k) decision of Substantially Equivalent on September 7, 2018, 30 days after the submission was received.
What is the product code of K182147?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.