Summit Nuclear: FDA clearances and approvals
Summit Nuclear has 6 FDA 510(k) clearances (first 1991, latest 1994), across 2 product codes in 1 review panel. Median 510(k) review time: 134 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 5 | 5 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
Review panels
- Radiology (6)
Most recent Summit Nuclear 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K935273 | VISION FX 40 & 80 SERIES GAMMA CAMERA | IYX | 1994-04-18 | 167 |
| K935318 | SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS | KPS | 1994-02-25 | 113 |
| K922427 | SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM | KPS | 1992-09-29 | 130 |
| K922426 | SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM | KPS | 1992-09-28 | 129 |
| K920958 | SUMMIT NUCLEAR VISION NEUROSPECT | KPS | 1992-08-07 | 171 |
| K912573 | VISION (NUCLEAR MEDICINE COMPUTER) | KPS | 1991-10-28 | 139 |
Recalls
openFDA lists no recalls under a recalling firm named Summit Nuclear.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Summit Nuclear have?
Summit Nuclear has 6 FDA 510(k) clearances (first 1991, latest 1994), across 2 product codes in 1 review panel.
How long does FDA take to clear Summit Nuclear's 510(k)s?
The median time from FDA receipt to decision across Summit Nuclear's cleared 510(k)s is 134 days.
What devices does Summit Nuclear make?
Its most frequent FDA product codes are KPS (System, Tomography, Computed, Emission, 5); IYX (Camera, Scintillation (Gamma), 1).
Has Summit Nuclear had device recalls?
openFDA lists no recalls under a recalling firm name matching Summit Nuclear. Related entities may recall under other names.
Next steps
- See all 6 Summit Nuclear clearances with predicates and recalls
- Run predicate analysis for product code KPS, Summit Nuclear's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.