LINEAR SCANNER PROBE ELSCINT LTD. TL-35
FDA 510(k) clearance K844189 · decided 1985-02-25
Clearance details
- K-number
- K844189
- Device name
- LINEAR SCANNER PROBE ELSCINT LTD. TL-35
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-10-30
- Decision date
- 1985-02-25
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- IYP
- Device class
- 1
- Regulation number
- 892.1370
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Elk Grove Village, IL, 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 |
|---|---|---|
| SCANMATE III (K921878) | Circadian, Inc. | 1992-09-11 |
| SUPERFLAB (K812893) | Mick Radio-Nuclear Instruments, Inc. | 1981-12-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GYREX (P840007/S003) | Elscint, Inc. | 1988-04-26 |
| GYREX, MODELS S3500 & S5000 (P840007/S002) | Elscint, Inc. | 1987-10-08 |
| GYREX, MODELS S3500 & S5000 (P840007/S001) | Elscint, Inc. | 1987-04-02 |