MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
FDA 510(k) clearance K013620 · decided 2002-01-22
Clearance details
- K-number
- K013620
- Device name
- MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
- Applicant
- Medstone Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-11-05
- Decision date
- 2002-01-22
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medstone Intl.
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 |
|---|---|---|
| TAP2D (K252649) | Nano-X Imaging , Ltd. | 2026-02-02 |
| Adaptix Ortho350 (K252133) | Adaptix Limited | 2025-11-06 |
| Nanox.ARC X (K250850) | Nano-X Imaging , Ltd. | 2025-04-16 |
| Nanox.ARC (K242395) | Nano-X Imaging , Ltd. | 2024-12-04 |
| Nanox.ARC (K222934) | Nano-X Imaging , Ltd. | 2023-04-28 |
| Ortho Device, ADAPTIX 3D Orthopedic Imaging System (K221949) | Pausch Medical GmbH | 2023-01-26 |
| CLISIS SYSTEMS, Discovery RF180 (K213081) | General Medical Merate S.P.A | 2021-10-26 |
| DR 600 with Tomosynthesis (K193262) | Agfa N.V. | 2020-03-09 |
| DR 800 with Tomosynthesis (K183275) | Agfa N.V. | 2019-02-01 |
| DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) (K132261) | Ge Medical Systems, LLC | 2013-11-18 |
| FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM (K121499) | Fujifilm Medical System U.S.A., Inc. | 2012-11-20 |
| PROGNOST ES, MODEL 0302 0000 (K011290) | Xmar Corp. | 2001-05-30 |
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 |