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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Radiation Measurements, Inc. — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

67 daysmedian FDA review time
131 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K893216RMI ULTRASOUND DOPPLER PHANTOM SYSTEMRadiation Measurements, Inc.1989-09-051310
K885223RMI SHORT DISTANCE ALIGNMENT DEVICERadiation Measurements, Inc.1989-02-17590
K873956ULTIMETERRadiation Measurements, Inc.1987-10-30320
K873836MAMMOGRAPHIC KVP METER MODEL 232Radiation Measurements, Inc.1987-10-16250
K854976RMI RESPIRATORY GATING SYSTEM MODEL 301Radiation Measurements, Inc.1986-05-071460
K834483DIGI-XRadiation Measurements, Inc.1984-03-05900
K834607ELECTRONIC KVP CASSETTERadiation Measurements, Inc.1984-02-21670
K834481DOPPLER PHANTOM FLOW CONTROL SYSRadiation Measurements, Inc.1984-01-25410
K834482TISSUE MIMICKING ULTRASOUND PHANTOMSRadiation Measurements, Inc.1984-01-25410
K837033ROTATABLE HALF BEAM SHIELDING BLOCK MODEL 440Radiation Measurements, Inc.1983-03-09850
K812949RMI TRANSILLUMINATOR, MODEL 292Radiation Measurements, Inc.1981-12-02420
K811108RMI TRANSILLUMINATION LIGHT METER #295Radiation Measurements, Inc.1981-07-01690

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda