FACTS MONOBLOCK
FDA 510(k) clearance K981267 · decided 1998-05-06
Clearance details
- K-number
- K981267
- Device name
- FACTS MONOBLOCK
- Applicant
- Dynarad Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-07
- Decision date
- 1998-05-06
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- IZX
- Device class
- 2
- Regulation number
- 892.1610
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Deer Park, NY, US
- Third-party review
- No
- Expedited review
- No
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| RINN UNIVERSAL COLLIMATOR (K932134) | Rinn Corp. | 1993-07-26 |
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| R-100-ET MANUAL COLLIMATOR (K900007) | Advantech | 1990-02-06 |
| R-150-ET COLLIMATOR (K896486) | Advantech | 1990-01-23 |
| COLLI-MATETM MODEL NO. B800 (K874687) | Summit Industries, Inc. | 1987-12-30 |
| COLLIMATOR MODEL A280BLMD & MODEL A280BLMP (K861941) | D&R X-Ray Products, Inc. | 1986-07-25 |
Recalls involving this device
No recalls on record reference this clearance.