Litton Medical Systems: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Litton Medical Systems” (first 1976, latest 1977), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 11 days. 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 | 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 3 | 3 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | 2 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 1 |
| IXR | Table, Radiographic, Tilting | 1 | 1 |
| KPW | Device, Beam Limiting, X-Ray, Diagnostic | 1 | 1 |
Review panels
- Radiology (8)
Most recent Litton Medical Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K770338 | X-RAY CONTROL & X-RAY HV GENERATOR | IZO | 1977-03-01 | 11 |
| K770337 | FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. | JAA | 1977-03-01 | 11 |
| K770336 | X-RAY TUBE, ROTATING ANODE | ITY | 1977-03-01 | 11 |
| K770334 | TILTING X-RAY TABLE | IXR | 1977-03-01 | 11 |
| K770333 | FLUOROSCOPE, C-ARM | JAA | 1977-03-01 | 11 |
| K770335 | COLLIMATOR, AUTOMATIC | KPW | 1977-02-28 | 10 |
| K760569 | THREE PHASE X-RAY CONTROLS & HV GENERATORS | IZO | 1976-09-15 | 13 |
| K760568 | SINGLE PHASE X-RAY CONTROLS & HV GENERATORS | IZO | 1976-09-15 | 13 |
Recalls
openFDA lists no recalls under a recalling firm named Litton Medical Systems.
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.
- Litton Medical Electronics (38 510(k)s)
- Litton Bionetics (15 510(k)s)
- Litton Dental Products (12 510(k)s)
- Litton Datamedix (5 510(k)s)
- Litton Systems, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Litton Medical Systems?
FDA lists 8 510(k) clearances under the applicant name “Litton Medical Systems” (first 1976, latest 1977), across 5 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 Litton Medical Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Litton Medical Systems is 11 days.
Which FDA product codes appear under Litton Medical Systems?
The most frequent FDA product codes under this applicant name are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 3); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 2); ITY (Assembly, Tube Housing, X-Ray, Diagnostic, 1).
Next steps
- See all 8 Litton Medical Systems clearances with predicates and recalls
- Run predicate analysis for product code IZO, Litton Medical Systems'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.