Subtle Medical Inc
Menlo Park, CA, US
Subtle Medical Inc appears in FDA device records in Menlo Park, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Subtle Medical Inc between 2018 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 2 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254120 | SubtleHD-CT (1.x) | QIH | Substantially Equivalent | |
| K254013 | SubtleHD-PET (1.x) | LLZ | Substantially Equivalent | |
| K243250 | SubtleHD (1.x) | QIH | Substantially Equivalent | |
| K240290 | AiMIFY (1.x) | LLZ | Substantially Equivalent | |
| K241329 | SubtleSYNTH (1.x) | QIH | Substantially Equivalent | |
| K233699 | SubtleREFORMAT (1.x) | LLZ | Substantially Equivalent | |
| K223623 | SubtleMR (2.3.x) | LLZ | Substantially Equivalent | |
| K211964 | SubtlePET | KPS | Substantially Equivalent | |
| K203182 | SubtleMR | LLZ | Substantially Equivalent | |
| K191688 | SubtleMR | LLZ | Substantially Equivalent | |
| K182336 | SubtlePET | KPS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015425142 | 3015425142 | Subtle Medical Inc | 883 Santa Cruz Avenue, Menlo Park, CA 94025 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain