TISSUE-EQUIVALENT BREAST SIMULATOR
FDA 510(k) clearance K865100 · decided 1987-01-12
Clearance details
- K-number
- K865100
- Device name
- TISSUE-EQUIVALENT BREAST SIMULATOR
- Applicant
- Computerized Imaging Reference Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-30
- Decision date
- 1987-01-12
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- IXF
- Device class
- 1
- Regulation number
- 892.1940
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Norfolk, VA, 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.
| Record | Firm | Date |
|---|---|---|
| DIGITAL SUBTRACTION ANTIOGRAPHY PHANTOM 76-700/711 (K851812) | Victoreen, Inc. | 1985-06-05 |
| DOPPLER PHANTOM FLOW CONTROL SYS (K834481) | Radiation Measurements, Inc. | 1984-01-25 |
| TISSUE MIMICKING ULTRASOUND PHANTOMS (K834482) | Radiation Measurements, Inc. | 1984-01-25 |
| 1.5` FOCAL SPOT RESOLUTION PATTERN (K810254) | Machlett Laboratories, Inc. | 1981-02-19 |
Recalls involving this device
No recalls on record reference this clearance.