Rapid SDH
FDA 510(k) K232436 · Ischemaview, Inc.
510(k) numberK232436
Submission
- Device name
- Rapid SDH
- Applicant
- Ischemaview, Inc.
Golden, CO, US - Received
- August 14, 2023
- Decision date
- October 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QAS – Radiological Computer-Assisted Triage And Notification Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2080
- Specialty
- Radiology
Radiological computer-assisted triage and notification software is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on…
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| 510(k) | Device | Decision |
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| K261085 | Rapid Vessel Occlusion (Rapid VO)QAS · Traditional | 07/13/2026SE |
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| K251533 | Rapid Obstructive Hydrocephalus, Rapid OHQAS · Traditional | 09/04/2025SE |
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| K251151 | Rapid CTA 360QAS · Traditional | 07/16/2025SE |
| K243378 | Rapid MLSQIH · Traditional | 05/28/2025SE |
| K243350 | Rapid Neuro3DQIH · Traditional | 01/22/2025SE |
| K233582 | RapidLLZ · Traditional | 04/22/2024SE |
| K232156 | Rapid ASPECTS (v3)POK · Traditional | 01/19/2024SE |
| K233512 | Rapid (6.0)QIH · Special | 01/16/2024SE |
Questions and answers
When was Rapid SDH cleared by the FDA?
Rapid SDH (K232436) received a 510(k) decision of Substantially Equivalent on October 25, 2023, 72 days after the submission was received.
What is the product code of K232436?
The FDA product code is QAS – Radiological Computer-Assisted Triage And Notification Software, a Class II (moderate risk) device regulated under 21 CFR 892.2080.