Subtle Medical, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Subtle Medical, Inc.” (first 2018, latest 2026), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 122 days, against 125 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 94 |
| 2019 | 1 | 84 |
| 2020 | 0 | — |
| 2021 | 2 | 109 |
| 2022 | 0 | — |
| 2023 | 1 | 157 |
| 2024 | 3 | 164 |
| 2025 | 1 | 120 |
| 2026 | 2 | 148 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Subtle Medical, Inc. took a median 122 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 125 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 6 | 6 |
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
| KPS | System, Tomography, Computed, Emission | 2 | 2 |
Review panels
- Radiology (11)
Most recent Subtle Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254120 | SubtleHD-CT (1.x) | QIH | 2026-05-15 | 147 |
| K254013 | SubtleHD-PET (1.x) | LLZ | 2026-05-14 | 150 |
| K243250 | SubtleHD (1.x) | QIH | 2025-02-12 | 120 |
| K240290 | AiMIFY (1.x) | LLZ | 2024-08-21 | 202 |
| K241329 | SubtleSYNTH (1.x) | QIH | 2024-07-11 | 62 |
| K233699 | SubtleREFORMAT (1.x) | LLZ | 2024-04-29 | 164 |
| K223623 | SubtleMR (2.3.x) | LLZ | 2023-05-11 | 157 |
| K211964 | SubtlePET | KPS | 2021-09-28 | 96 |
| K203182 | SubtleMR | LLZ | 2021-02-26 | 122 |
| K191688 | SubtleMR | LLZ | 2019-09-16 | 84 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Subtle Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Subtle Medical, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06224543: MR Image Synthesis With Low Gadobutrol Dose and AI (Completed, started 2023-06-16)
Frequently asked questions
How many FDA 510(k) clearances are listed under Subtle Medical, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Subtle Medical, Inc.” (first 2018, latest 2026), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Subtle Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Subtle Medical, Inc. is 122 days. Since 2017: 122 days, versus 125 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Subtle Medical, Inc.?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 6); QIH (Automated Radiological Image Processing Software, 3); KPS (System, Tomography, Computed, Emission, 2).
Next steps
- See all 11 Subtle Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Subtle Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.