Ge Medical Systems F.I. Haifa: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Ge Medical Systems F.I. Haifa” (first 1998, latest 2013), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 25 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 | 1 | 14 |
| 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 |
|---|---|---|---|
| KPS | System, Tomography, Computed, Emission | 14 | 14 |
| LLZ | System, Image Processing, Radiological | 3 | 3 |
Review panels
- Radiology (17)
Most recent Ge Medical Systems F.I. Haifa 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130884 | XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION | LLZ | 2013-04-12 | 14 |
| K093982 | XELERIS 3 PROCESSING AND REVIEW WORKSTATION | LLZ | 2010-01-08 | 15 |
| K093514 | DISCOVERY MODEL NM/CT 670 | KPS | 2009-12-10 | 27 |
| K083504 | GE DISCOVERY NM/CT 570C | KPS | 2008-12-12 | 16 |
| K080124 | VENTRI 1.1 | KPS | 2008-01-31 | 14 |
| K051855 | VENTRI | KPS | 2005-08-02 | 25 |
| K043381 | INFINIA LIGHTSPEED | KPS | 2004-12-23 | 14 |
| K033874 | MYOLIGHT | KPS | 2003-12-30 | 15 |
| K023932 | GE PHOTON ENERGY RECOVERY (PER) OPTION | KPS | 2002-12-11 | 15 |
| K022960 | GE QUASAR NUCLEAR MEDICINE SYSTEM | KPS | 2002-09-19 | 13 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ge Medical Systems F.I. Haifa.
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 F.I. Haifa?
FDA lists 17 510(k) clearances under the applicant name “Ge Medical Systems F.I. Haifa” (first 1998, latest 2013), 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 Medical Systems F.I. Haifa?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ge Medical Systems F.I. Haifa is 25 days.
Which FDA product codes appear under Ge Medical Systems F.I. Haifa?
The most frequent FDA product codes under this applicant name are KPS (System, Tomography, Computed, Emission, 14); LLZ (System, Image Processing, Radiological, 3).
Next steps
- See all 17 Ge Medical Systems F.I. Haifa clearances with predicates and recalls
- Run predicate analysis for product code KPS, Ge Medical Systems F.I. Haifa'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.