Ge Lunar Corp.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Ge Lunar Corp.” (first 2001, latest 2003), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 58 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 | 3 | 3 |
| MUA | Bone Sonometer | 1 | 0 |
Review panels
- Radiology (4)
Most recent Ge Lunar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER | KGI | 2003-07-25 | 120 |
| K023554 | DUAL-ENERGY VERTEBRAL ASSESSMENT VIEW SOFTWARE | KGI | 2002-12-20 | 58 |
| K011917 | ADVANCED HIP ASSESSMENT SOFTWARE | KGI | 2001-08-03 | 44 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970040 | PMA | ACHILLES EXPRESS ULTRASONOMETER | 1998-06-26 |
Recalls
openFDA lists no recalls under a recalling firm named Ge Lunar Corp..
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 Lunar Corp.?
FDA lists 3 510(k) clearances under the applicant name “Ge Lunar Corp.” (first 2001, latest 2003), plus 1 PMA decision, 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 Ge Lunar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Lunar Corp. is 58 days.
Which FDA product codes appear under Ge Lunar Corp.?
The most frequent FDA product codes under this applicant name are KGI (Densitometer, Bone, 3); MUA (Bone Sonometer, 1).
Next steps
- See all 3 Ge Lunar Corp. clearances with predicates and recalls
- Run predicate analysis for product code KGI, Ge Lunar Corp.'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.