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

Spectrum X-Ray Corp. — Predicate Candidate Screening

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

48 daysmedian FDA review time

146 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days
K933134	SPECTRUM DG-P7000 PEDIATRIC CRADLE	Spectrum X-Ray Corp.	1993-10-07	101
K931563	SPECTRUM MARK I SPECIAL PROCEDURES TABLE	Spectrum X-Ray Corp.	1993-08-23	146
K870707	PENTAMAX 1 MODEL B TABLE SYSTEM	Spectrum X-Ray Corp.	1987-05-14	83
K834494	SPECTRUM X-RAY CORP	Spectrum X-Ray Corp.	1984-02-21	69
K840463	DIGITAL CRADLE	Spectrum X-Ray Corp.	1984-02-21	19
K827450	SIMPLAMATIC III	Spectrum X-Ray Corp.	1982-05-19	22
K813561	SPECTRUM PEDIATRIC CARDLE TABLE	Spectrum X-Ray Corp.	1982-01-29	38
K791812	SPECTRUM EMERGENCY & TRAUMA TABLE SYSTEM	Spectrum X-Ray Corp.	1979-11-05	48
K791811	SPECTRUM AUTOMATIC CHEST UNIT MODEL C	Spectrum X-Ray Corp.	1979-10-26	38

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