XACT Robotic System, ACE Model
FDA 510(k) K213759 · Xact Robotics, Ltd.
510(k) numberK213759
Submission
- Device name
- XACT Robotic System, ACE Model
- Applicant
- Xact Robotics, Ltd.
Caesarea, IL - Received
- November 30, 2021
- Decision date
- September 23, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
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Questions and answers
When was XACT Robotic System, ACE Model cleared by the FDA?
XACT Robotic System, ACE Model (K213759) received a 510(k) decision of Substantially Equivalent on September 23, 2022, 297 days after the submission was received.
What is the product code of K213759?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.