Atlas FDA

ULTIMETER

FDA 510(k) clearance K873956 · decided 1987-10-30

Clearance details

K-number
K873956
Device name
ULTIMETER
Applicant
Radiation Measurements, Inc.
Decision
Substantially Equivalent
Date received
1987-09-28
Decision date
1987-10-30
Days to decision
32 days
Clearance type
Traditional
Product code
LHO
Device class
1
Regulation number
892.1940
Medical specialty
Radiology
Advisory committee
Radiology
Location
Middleton, WI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (K042733)Standard Imaging, Inc.2004-11-15
MULTI PURPOSE MODEL 76-903 (K860260)Victoreen, Inc.1986-05-07
MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (K853754)Victoreen, Inc.1986-05-07
MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (K860100)Victoreen, Inc.1986-04-22
BDS-3 BEAM DATA SCANNER (K844620)Varian Assoc., Inc.1985-07-01
RFA-7 RADIATION FIELD ANALYZER (K845007)Varian Assoc., Inc.1985-07-01
DIGI-X (K834483)Radiation Measurements, Inc.1984-03-05

Recalls involving this device

No recalls on record reference this clearance.