STS(TM) FLUOROSCOPIC IMAGING MODULE
FDA 510(k) clearance K905278 · decided 1991-02-04
Clearance details
- K-number
- K905278
- Device name
- STS(TM) FLUOROSCOPIC IMAGING MODULE
- Applicant
- Medstone Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-23
- Decision date
- 1991-02-04
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- JAA
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MEDSTONE STS-TC/U LITHOTRIPTER (P970042/S003) | Medstone Intl., Inc. | 2003-02-14 |
| MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (P970042/S004) | Medstone Intl., Inc. | 2003-01-28 |
| MEDSTONE STS LITHOTRIPTER (P970042/S002) | Medstone Intl., Inc. | 2002-08-20 |
| MEDSTONE STS LITHOTRIPTER (P970042/S001) | Medstone Intl., Inc. | 2001-02-05 |
| MEDSTONE STS LITHOTRIPTER (P970042) | Medstone Intl., Inc. | 2000-09-05 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S036) | Medstone Intl., Inc. | 2000-07-26 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S035) | Medstone Intl., Inc. | 2000-02-25 |
| TRANSPORTABLE MODEL STS-T LITHOTRIPTER (P870015/S034) | Medstone Intl., Inc. | 1999-11-19 |