510(k) K200755
- Device
- Caption Guidance
- Applicant
- Caption Health
- 510(k) number
- K200755
- Product code
- QJU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-16
- Date received
- 2020-03-23
- Regulation
- 892.2100
- Classification name
- Image Acquisition And/or Optimization Guided By Artificial Intelligence
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sam Surette
- Address
- 2000 Sierra Pt. Pkwy. Brisbane CA US 94005 94005
FDA Registration Numbers#
- 3029923647
- 3032008018
- 3040362673
Source Documents#
Other 510(k) Records For Product Code QJU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260780 | HeartFocus | Deski | 2026-06-03 |
| K251416 | UltraSight Guidance | Ultrasight , Ltd. | 2025-12-17 |
| K242807 | HeartFocus (V.1.1.1) | Deski | 2025-04-04 |
| K243065 | Cardiac Guidance | Caption Health, Inc. | 2025-01-15 |
| K223347 | UltraSight AI Guidance | Ultrasight, Inc. | 2023-07-24 |
| K201992 | Caption Guidance | Caption Health | 2020-09-18 |
| DEN190040 | Caption Guidance | Bay Labs, Inc. | 2020-02-07 |
Legacy Summary#
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FDA Review#
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