Quantum Medical Imaging, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Quantum Medical Imaging, LLC” (first 2001, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 36 days. 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (5)
Most recent Quantum Medical Imaging, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083181 | QV-9000 UNIVERSAL SYSTEM | KPR | 2008-11-26 | 29 |
| K080905 | QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI | LLZ | 2008-07-16 | 106 |
| K072010 | QUANTUM DIREX SYSTEM | KPR | 2007-08-07 | 15 |
| K023008 | UNIVERSAL SYSTEM, MODEL QV-800 | KPR | 2002-11-13 | 65 |
| K011486 | Q-RAD RADIOGRAPHIC SYSTEM | KPR | 2001-06-20 | 36 |
Recalls
openFDA lists no recalls under a recalling firm named Quantum Medical Imaging, LLC.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Quantum Orthopedics, Inc. (6 510(k)s)
- Quantum Medical Systems, Inc. (5 510(k)s)
- Quantum Bioengineering, Ltd. (4 510(k)s)
- Quantum Co., Ltd. (3 510(k)s)
- Quantum Devices, Inc. (2 510(k)s)
- Quantum Instruments Corp. (2 510(k)s)
- Quantum Medical Concepts, LLC (2 510(k)s)
- Quantum Surgical Sas (2 510(k)s)
- Quantum Dental Technologies, Inc. (1 510(k)s)
- Quantum Diagnostics, Ltd. (1 510(k)s)
- Quantum Intl. (1 510(k)s)
- Quantum Life Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Quantum Medical Imaging, LLC?
FDA lists 5 510(k) clearances under the applicant name “Quantum Medical Imaging, LLC” (first 2001, latest 2008), across 2 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 Quantum Medical Imaging, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantum Medical Imaging, LLC is 36 days.
Which FDA product codes appear under Quantum Medical Imaging, LLC?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 4); LLZ (System, Image Processing, Radiological, 1).
Next steps
- See all 5 Quantum Medical Imaging, LLC clearances with predicates and recalls
- Run predicate analysis for product code KPR, Quantum Medical Imaging, LLC'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.