BriefCase-Quantification
FDA 510(k) K231631 · Aidoc Medical , Ltd.
510(k) numberK231631
Submission
- Device name
- BriefCase-Quantification
- Applicant
- Aidoc Medical , Ltd.
Tell-Aviv, IL - Received
- June 5, 2023
- Decision date
- November 28, 2023
- 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 |
|---|---|---|
| K261317 | BriefCase-TriageQAS · Special | 05/14/2026SE |
| K253578 | BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large…QAS · Traditional | 02/26/2026SE |
| K251195 | BriefCase-TriageQAS · Traditional | 01/27/2026SE |
| K252970 | BriefCase-Triage: CARE Multi-triage CT BodyQAS · Traditional | 01/07/2026SE |
| K253265 | BriefCase-TriageQAS · Special | 11/06/2025SE |
| K251406 | BriefCase-TriageQAS · Special | 05/30/2025SE |
| K250248 | BriefCase-TriageQAS · Special | 02/14/2025SE |
| K243548 | BriefCase-TriageQFM · Special | 12/11/2024SE |
| K242203 | BriefCase-QuantificationQIH · Traditional | 11/22/2024SE |
| K242837 | BriefCase-TriageQAS · Special | 10/18/2024SE |
Questions and answers
When was BriefCase-Quantification cleared by the FDA?
BriefCase-Quantification (K231631) received a 510(k) decision of Substantially Equivalent on November 28, 2023, 176 days after the submission was received.
What is the product code of K231631?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.