BONE DENSITY CT PHANTOM
FDA 510(k) clearance K852528 · decided 1985-09-26
Clearance details
- K-number
- K852528
- Device name
- BONE DENSITY CT PHANTOM
- Applicant
- Computerized Imaging Reference Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-14
- Decision date
- 1985-09-26
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- IXG
- Device class
- 1
- Regulation number
- 892.1950
- 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 |
|---|---|---|
| BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE (K913243) | Bennett X-Ray Corp. | 1991-09-19 |
| COMPUTED TOMOGRAPHY CALIBRATION PHANT (K840131) | Imatron, Inc. | 1984-02-21 |
| SERIES OF DIAGNOSTIC PHANTOMS (K834465) | Cirs, Inc. | 1984-02-21 |
Recalls involving this device
No recalls on record reference this clearance.