Lunar Corp.: FDA filings under this applicant name
FDA lists 29 510(k) clearances under the applicant name “Lunar Corp.” (first 1989, latest 2000), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 80 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 | 26 | 26 |
| JAK | System, X-Ray, Tomography, Computed | 1 | 1 |
| KPS | System, Tomography, Computed, Emission | 1 | 1 |
| OXO | Image-Intensified Fluoroscopic X-Ray System, Mobile | 1 | 1 |
Review panels
- Radiology (29)
Most recent Lunar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001812 | PEDIATRIC REFERENCE DATA | KGI | 2000-07-10 | 25 |
| K001756 | LUNAR REPORT GENERATOR II | KGI | 2000-07-06 | 27 |
| K000826 | PRODIGY LATERAL VIEW SOFTWARE | KGI | 2000-04-14 | 31 |
| K983724 | ORCA-DX BONE DENSITOMETER | KGI | 1998-12-08 | 47 |
| K983564 | PRODIGY TOTAL BODY SOFTWARE | KGI | 1998-12-08 | 56 |
| K983271 | FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS | KGI | 1998-11-18 | 62 |
| K983269 | FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER | KGI | 1998-11-18 | 62 |
| K983262 | FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS | KGI | 1998-11-18 | 62 |
| K982267 | DPX-RX BONE DENSITOMETER | KGI | 1998-08-18 | 50 |
| K974437 | EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE | KGI | 1998-02-13 | 81 |
19 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 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.
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.
- Lunar Radiation Corp. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lunar Corp.?
FDA lists 29 510(k) clearances under the applicant name “Lunar Corp.” (first 1989, latest 2000), across 4 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 Lunar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lunar Corp. is 80 days.
Which FDA product codes appear under Lunar Corp.?
The most frequent FDA product codes under this applicant name are KGI (Densitometer, Bone, 26); JAK (System, X-Ray, Tomography, Computed, 1); KPS (System, Tomography, Computed, Emission, 1).
Next steps
- See all 29 Lunar Corp. clearances with predicates and recalls
- Run predicate analysis for product code KGI, 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.