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510(k) Data Aggregation
K Number
K964562Device Name
DTX-200 BONE DENSITOMETER
Manufacturer
OSTEOMETER MEDITECH A/S
Date Cleared
1997-08-22
(282 days)
Product Code
KGI
Regulation Number
892.1170Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMETER MEDITECH A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²) in the distal section of the forearm.
Device Description
The DTX-200 candidate device is a dual energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath. The X-Ray generator is driven at 55 Kv, with a current of 0.3 mAmps. The detector uses a scintillating crystal and a solid state dual energy sandwich detector. A highly stable X-Ray output, together with a source collimation of 1 mm diameter, and excellent pixel resolution, yields images of very high quality. The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.1 micro Sievert per scan. Both the DTX-200 candidate and the DTX-200 predicate bone densitometer devices consist of a computer, keyboard, monitor, printer, and scanner system using an X-ray transmission source. The DTX-200 candidate device and the DTX-200 predicate device are identical and use dual X-ray photon absorptiometry (DXA) to estimate bone mineral content (BMC) and bone mineral density (BMD). Both the candidate and predicate DTX-200 devices are identical and use water as soft tissue equivalent material. Both the DTX-200 candidate device and the DTX-200 predicate device use a line-by-line calibration system, ensuring good precision.
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K Number
K963789Device Name
DTX-100 BONE DENSITOMETER
Manufacturer
OSTEOMETER MEDITECH A/S
Date Cleared
1997-07-14
(297 days)
Product Code
KGI
Regulation Number
892.1170Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMETER MEDITECH A/S
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Estimate bone mineral content (BMC in grams) and bone mineral density (BMD in grams/cm²) in the distal section of the forearm.
Device Description
The DTX-100 candidate device is a single energy system, where the measured object, in this case the forearm, is submerged into a soft tissue equivalent water bath. The X-Ray generator is driven at 40 kV, with a current of 0.2 mAmps. The detector uses scintillating crystal and a photomultiplier tube. A highly stable X-Ray output, together with a source collimation of 1 mm, and excellent pixel resolution, yields images of very high quality. The typical time to estimate bone mineral content and bone mineral density is approximately 3.0 to 4.5 minutes. The effective patient dose is estimated to be 0.01 micro Sievert per scan.
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