510(k) K865100
- Device
- TISSUE-EQUIVALENT BREAST SIMULATOR
- Applicant
- COMPUTERIZED IMAGING REFERENCE SYSTEMS, INC.
- 510(k) number
- K865100
- Product code
- IXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-12
- Date received
- 1986-12-30
- Regulation
- 892.1940
- Classification name
- Test-pattern, Radiographic
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM R DRURY
- Address
- 2488b Almeda Ave. Norfolk VA US 23513 23513
FDA Registration Numbers#
- 1316463
- 1320150
- 3013695852
- 3009607881
- 1226773
- 3003768277
- 2126677
- 3006087789
- 2182762
- 3011168908
- 1529041
- 3012889794
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IXF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851812 | DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 | Victoreen, Inc. | 1985-06-05 |
| K834481 | DOPPLER PHANTOM FLOW CONTROL SYS | Radiation Measurements, Inc. | 1984-01-25 |
| K834482 | TISSUE MIMICKING ULTRASOUND PHANTOMS | Radiation Measurements, Inc. | 1984-01-25 |
| K810254 | 1.5` FOCAL SPOT RESOLUTION PATTERN | Machlett Laboratories, Inc. | 1981-02-19 |
Legacy Summary#
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FDA Review#
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