AI-Rad Companion (Pulmonary)
FDA 510(k) K213713 · Siemens Healthcare GmbH
510(k) numberK213713
Submission
- Device name
- AI-Rad Companion (Pulmonary)
- Applicant
- Siemens Healthcare GmbH
Malvern, PA, US - Received
- November 24, 2021
- Decision date
- August 11, 2022
- 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 |
|---|---|---|
| K253264 | myAblation Guide (VC10A)QTZ · Traditional | 06/16/2026SE |
| K253689 | syngo Dynamics (VA41F)QIH · Traditional | 04/10/2026SE |
| K252548 | AI-Rad Companion Organs RTQKB · Traditional | 04/10/2026SE |
| K253057 | AI-Rad Companion Brain MRQIH · Traditional | 01/22/2026SE |
| K252838 | MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…LNH · Traditional | 12/19/2025SE |
| K252608 | AI-Rad Companion Prostate MRLLZ · Traditional | 09/09/2025SE |
| K250443 | MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH · Traditional | 06/16/2025SE |
| K242551 | syngo Dynamics (Version VA41D)QIH · Traditional | 04/03/2025SE |
| K242745 | AI-Rad Companion Organs RTQKB · Traditional | 03/27/2025SE |
| K241770 | Prostate MR AI (VA10A)QDQ · Traditional | 03/05/2025SE |
Questions and answers
When was AI-Rad Companion (Pulmonary) cleared by the FDA?
AI-Rad Companion (Pulmonary) (K213713) received a 510(k) decision of Substantially Equivalent on August 11, 2022, 260 days after the submission was received.
What is the product code of K213713?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.