Omega Medical Imaging, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Omega Medical Imaging, Inc.” (first 1990, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 126 days, against 103 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 |
|---|---|---|
| 2012 | 1 | 87 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 241 |
| 2019 | 2 | 136 |
| 2020 | 0 | — |
| 2021 | 2 | 104 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 138 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Omega Medical Imaging, Inc. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 8 | 8 |
| OWB | Interventional Fluoroscopic X-Ray System | 5 | 5 |
| IZW | Collimator, Automatic, Radiographic | 2 | 2 |
Review panels
- Radiology (15)
Most recent Omega Medical Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242488 | Soteria E-View | JAA | 2025-01-06 | 138 |
| K212890 | Nyquist.IQ | JAA | 2021-12-13 | 94 |
| K212336 | Soteria.AI | OWB | 2021-11-17 | 113 |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | JAA | 2019-10-04 | 100 |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | JAA | 2019-03-29 | 171 |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | OWB | 2018-02-09 | 241 |
| K121293 | CS-SERIES-FP WITH 3030+OPTION | JAA | 2012-07-26 | 87 |
| K100102 | CS-SERIES-FP | OWB | 2010-08-31 | 230 |
| K093572 | R650 QDASM COLLIMATOR | IZW | 2010-02-03 | 77 |
| K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | OWB | 2007-05-18 | 52 |
5 earlier clearances. See the full list in Caduvo.
Recalls
4 product recalls in 4 recall events; 2 initiated in the last five years. Most recent: 2023-09-08.
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.
- Omega Medical Electronics (21 510(k)s)
- Omega Laboratories, Inc. (9 510(k)s)
- Omega Medical Diagnostics (5 510(k)s)
- Omega Silicone, Inc. (5 510(k)s)
- Omega Surgical Instruments, Inc. (3 510(k)s)
- Omega Universal Technologies, Ltd. (3 510(k)s)
- Omega Medical Corp. (2 510(k)s)
- Omega Critical Care Limited (1 510(k)s)
- Omega Group, Inc. (1 510(k)s)
- Omega Hearing Aid Center (1 510(k)s)
- Omega Mark-3 Pen Corp. (1 510(k)s)
- Omega Medical Services, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omega Medical Imaging, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Omega Medical Imaging, Inc.” (first 1990, latest 2025), 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 Omega Medical Imaging, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omega Medical Imaging, Inc. is 94 days. Since 2017: 126 days, versus 103 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Omega Medical Imaging, Inc.?
The most frequent FDA product codes under this applicant name are JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 8); OWB (Interventional Fluoroscopic X-Ray System, 5); IZW (Collimator, Automatic, Radiographic, 2).
Next steps
- See all 15 Omega Medical Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAA, Omega Medical Imaging, 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.