Nucleus.io
510(k) K203249
Nucleus.io is a Class II device made by Nucleushealth, LLC, cleared under FDA 510(k) K203249 on 4 Dec 2020, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203249 | Date4 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K203249
Recalls
-
- Ongoing Z-0551-2024
Under certain circumstances, information from HL7 messages received by Stratus PACS/Imaging Share systems has been incorrectly associated with another patient's study.
Timeline
- Cleared FDA 510(k) K203249
- Recall initiated FDA recalls Z-0551-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203249
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Change Healthcare Stratus Imaging PACS 0.6.0 | 0.6.0 | 17540262160017 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 0.7.0 | 0.7.0 | 17540262160024 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.0.0 | 1.0.0 | 17540262160031 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.0.1 | 1.0.1 | 17540262160055 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.1.0 | 1.1.0 | 17540262160048 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.1.1 | 1.1.1 | 17540262160062 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.2.0 | 1.2.0 | 17540262160079 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.3.0 | 1.3.0 | 17540262160086 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.0 | 1.4.0 | 17540262160093 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.1 | 1.4.1 | 17540262160109 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.3 | 1.4.3 | 17540262160116 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.5 | 1.4.5 | 17540262160130 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.6 | 1.4.6 | 17540262160147 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.7 | 1.4.7 | 17540262160161 | — | No longer on the market |
| Change Healthcare Stratus Imaging PACS 1.4.8 | 1.4.8 | 17540262160178 | — | On the market |
| Nucleus.io 25.0 | 25.0 | 17540262140026 | — | On the market |
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