BIAD NUCLEAR IMAGING SYSTEM
FDA 510(k) clearance K892875 · decided 1989-07-20
Clearance details
- K-number
- K892875
- Device name
- BIAD NUCLEAR IMAGING SYSTEM
- Applicant
- Trionix Research Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-19
- Decision date
- 1989-07-20
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Twinsburg, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Trionix Research Laboratory
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Fu recall (Z-0193-2007) | Trionix Research Laboratory Inc | 2006-11-16 |