Spectrum X-Ray Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Spectrum X-Ray Corp.” (first 1979, latest 1993), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| IXR | Table, Radiographic, Tilting | 3 | 3 |
| KXH | Cradle, Patient, Radiologic | 3 | 3 |
| IZZ | Table, Radiographic, Non-Tilting, Powered | 1 | 1 |
| KPX | Changer, Radiographic Film/Cassette | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (8)
Most recent Spectrum X-Ray Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933134 | SPECTRUM DG-P7000 PEDIATRIC CRADLE | KXH | 1993-10-07 | 101 |
| K931563 | SPECTRUM MARK I SPECIAL PROCEDURES TABLE | IXR | 1993-08-23 | 146 |
| K870707 | PENTAMAX 1 MODEL B TABLE SYSTEM | IXR | 1987-05-14 | 83 |
| K840463 | DIGITAL CRADLE | KXH | 1984-02-21 | 19 |
| K834494 | SPECTRUM X-RAY CORP | IZZ | 1984-02-21 | 69 |
| K827450 | SIMPLAMATIC III | — | 1982-05-19 | 22 |
| K813561 | SPECTRUM PEDIATRIC CARDLE TABLE | KXH | 1982-01-29 | 38 |
| K791812 | SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM | IXR | 1979-11-05 | 48 |
| K791811 | SPECTRUM AUTOMATIC CHEST UNIT MODEL C | KPX | 1979-10-26 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Spectrum X-Ray 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.
- Spectrum Designs, Inc. (18 510(k)s)
- Spectrum Medical , Ltd. (15 510(k)s)
- Spectrum Dynamics Medical, Ltd. (8 510(k)s)
- Spectrum Spine, LLC (8 510(k)s)
- Spectrum Medical S.R.L. (6 510(k)s)
- Spectrum Vascular (6 510(k)s)
- Spectrum Co. (3 510(k)s)
- Spectrum Diagnostic, Inc. (3 510(k)s)
- Spectrum Dynamics , Ltd. (3 510(k)s)
- Spectrum Medical Technologies, Inc. (3 510(k)s)
- Spectrum Medical, Llp (2 510(k)s)
- Spectrum Antimicrobials, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spectrum X-Ray Corp.?
FDA lists 9 510(k) clearances under the applicant name “Spectrum X-Ray Corp.” (first 1979, latest 1993), 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 Spectrum X-Ray Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spectrum X-Ray Corp. is 48 days.
Which FDA product codes appear under Spectrum X-Ray Corp.?
The most frequent FDA product codes under this applicant name are IXR (Table, Radiographic, Tilting, 3); KXH (Cradle, Patient, Radiologic, 3); IZZ (Table, Radiographic, Non-Tilting, Powered, 1).
Next steps
- See all 9 Spectrum X-Ray Corp. clearances with predicates and recalls
- Run predicate analysis for product code IXR, Spectrum X-Ray 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.