Radiation Measurements, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Radiation Measurements, Inc.” (first 1981, latest 1989), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| HJM | Transilluminator, Ac-Powered | 2 | 2 |
| IXF | Test-Pattern, Radiographic | 2 | 2 |
| LHO | Instrument, Quality-Assurance, Radiologic | 2 | 2 |
| GXX | Block, Test, Ultrasonic Scanner Calibration | 1 | 1 |
| IWN | Cassette, Measurement, Ardran-Crooks | 1 | 1 |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | 1 | 1 |
| IZH | System, X-Ray, Mammographic | 1 | 1 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (8)
- Ophthalmic (2)
- Neurology (1)
Most recent Radiation Measurements, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K893216 | RMI ULTRASOUND DOPPLER PHANTOM SYSTEM | GXX | 1989-09-05 | 131 |
| K885223 | RMI SHORT DISTANCE ALIGNMENT DEVICE | LNH | 1989-02-17 | 59 |
| K873956 | ULTIMETER | LHO | 1987-10-30 | 32 |
| K873836 | MAMMOGRAPHIC KVP METER MODEL 232 | IZH | 1987-10-16 | 25 |
| K854976 | RMI RESPIRATORY GATING SYSTEM MODEL 301 | IXO | 1986-05-07 | 146 |
| K834483 | DIGI-X | LHO | 1984-03-05 | 90 |
| K834607 | ELECTRONIC KVP CASSETTE | IWN | 1984-02-21 | 67 |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | IXF | 1984-01-25 | 41 |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | IXF | 1984-01-25 | 41 |
| K837033 | ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440 | — | 1983-03-09 | 85 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Radiation Measurements, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Radiation Measurements, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
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.
- Radiation Products Design, Inc. (8 510(k)s)
- Radiation Technology, Inc. (7 510(k)s)
- Radiation Development Co., Inc. (2 510(k)s)
- Radiation Monitoring Devices, Inc. (2 510(k)s)
- Radiation Oncology Computer Systems (2 510(k)s)
- Radiation Safety & Nuclear Products, Inc. (2 510(k)s)
- Radiation Products, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Radiation Measurements, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Radiation Measurements, Inc.” (first 1981, latest 1989), across 9 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Radiation Measurements, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Radiation Measurements, Inc. is 63 days.
Which FDA product codes appear under Radiation Measurements, Inc.?
The most frequent FDA product codes under this applicant name are HJM (Transilluminator, Ac-Powered, 2); IXF (Test-Pattern, Radiographic, 2); LHO (Instrument, Quality-Assurance, Radiologic, 2).
Next steps
- See all 12 Radiation Measurements, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HJM, Radiation Measurements, Inc.'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.