DIGI-X
FDA 510(k) clearance K834483 · decided 1984-03-05
Clearance details
- K-number
- K834483
- Device name
- DIGI-X
- Applicant
- Radiation Measurements, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-06
- Decision date
- 1984-03-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LHO
- Device class
- 1
- Regulation number
- 892.1940
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Radiation Measurements
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.
| Record | Firm | Date |
|---|---|---|
| STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM (K042733) | Standard Imaging, Inc. | 2004-11-15 |
| ULTIMETER (K873956) | Radiation Measurements, Inc. | 1987-10-30 |
| MULTI PURPOSE MODEL 76-903 (K860260) | Victoreen, Inc. | 1986-05-07 |
| MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901 (K853754) | Victoreen, Inc. | 1986-05-07 |
| MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902 (K860100) | Victoreen, Inc. | 1986-04-22 |
| BDS-3 BEAM DATA SCANNER (K844620) | Varian Assoc., Inc. | 1985-07-01 |
| RFA-7 RADIATION FIELD ANALYZER (K845007) | Varian Assoc., Inc. | 1985-07-01 |
Recalls involving this device
No recalls on record reference this clearance.