Quantum Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Quantum Medical Systems, Inc.” (first 1985, latest 1991), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 199 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 3 | 3 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
| MAA | Monitor, Fetal Doppler Ultrasound | 1 | 1 |
Review panels
- Radiology (5)
Most recent Quantum Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K904019 | QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM | IYO | 1991-03-22 | 204 |
| K894992 | QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM | MAA | 1990-02-23 | 199 |
| K890998 | QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL. | IYN | 1989-05-02 | 88 |
| K860581 | QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM | IYO | 1987-02-13 | 360 |
| K853217 | QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES | IYO | 1985-12-30 | 151 |
Recalls
openFDA lists no recalls under a recalling firm named Quantum Medical Systems, 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.
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 Imaging, LLC (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 Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Quantum Medical Systems, Inc.” (first 1985, latest 1991), 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 Quantum Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Quantum Medical Systems, Inc. is 199 days.
Which FDA product codes appear under Quantum Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 3); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 1); MAA (Monitor, Fetal Doppler Ultrasound, 1).
Next steps
- See all 5 Quantum Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Quantum Medical Systems, 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.