Ge Medical Systems Ultrasound and Primary Care Dia: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ge Medical Systems Ultrasound and Primary Care Dia” (first 2004, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 17 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under GE HealthCare, based on public ownership records.
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 |
|---|---|---|---|
| KGI | Densitometer, Bone | 4 | 4 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
Review panels
- Radiology (7)
Most recent Ge Medical Systems Ultrasound and Primary Care Dia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103730 | GE LUNAR VISCERAL FAT SOFTWARE | KGI | 2011-05-06 | 136 |
| K072664 | GE LUNAR FEMUR STRENGTH SOFTWARE | KGI | 2008-11-21 | 428 |
| K082185 | GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 | IYO | 2008-08-15 | 14 |
| K073408 | GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM | IYN | 2007-12-19 | 15 |
| K072439 | GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT | KGI | 2007-09-14 | 15 |
| K052581 | LUNAR IDXA | KGI | 2005-10-20 | 30 |
| K041813 | GE LOGIQ 7 ULTRASOUND BT04 | IYN | 2004-07-23 | 17 |
Recalls
openFDA lists no recalls under a recalling firm named Ge Medical Systems Ultrasound and Primary Care Dia.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ge Medical Systems Ultrasound and Primary Care Dia?
FDA lists 7 510(k) clearances under the applicant name “Ge Medical Systems Ultrasound and Primary Care Dia” (first 2004, latest 2011), 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 Ge Medical Systems Ultrasound and Primary Care Dia?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Medical Systems Ultrasound and Primary Care Dia is 17 days.
Which FDA product codes appear under Ge Medical Systems Ultrasound and Primary Care Dia?
The most frequent FDA product codes under this applicant name are KGI (Densitometer, Bone, 4); IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 2); IYO (System, Imaging, Pulsed Echo, Ultrasonic, 1).
Next steps
- See all 7 Ge Medical Systems Ultrasound and Primary Care Dia clearances with predicates and recalls
- Run predicate analysis for product code KGI, Ge Medical Systems Ultrasound and Primary Care Dia'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.