TCA 5R / 5S
FDA 510(k) clearance K070123 · decided 2007-03-09
Clearance details
- K-number
- K070123
- Device name
- TCA 5R / 5S
- Applicant
- Dornier Medtech America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-01-16
- Decision date
- 2007-03-09
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dornier Medtech America
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 |
|---|---|---|
| Zenition 30 (K254205) | Philips Medical Systems Nederland B.V. | 2026-08-07 |
| Shield System (Siemens 30x40) (K260607) | Radiaction , Ltd. | 2026-07-31 |
| SmartCT (R3.0 (L10)) (K253670) | Philips Medical Systems B.V. | 2026-07-10 |
| C-beam (K252735) | Pulmera, Inc. | 2026-05-22 |
| Intelligent NR (K252503) | Canon, Inc. | 2026-04-30 |
| ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (K254173) | Siemens Medical Solutions USA, Inc. | 2026-04-24 |
| ARTIS genio floor; ARTIS icono.explore floor (K253752) | Siemens Medical Solutions USA, Inc. | 2026-04-23 |
| BELLIGER ACE (K252229) | Genoray Co., Ltd. | 2026-04-02 |
| Trinias (K252099) | Shimadzu Corporation | 2026-03-24 |
| Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) (K253584) | Canon Medical Systems Corporation | 2026-03-10 |
| CARA System (K252500) | Cara Medical, Ltd. | 2026-02-20 |
| ArmSure Fluoroscopic Positioning System (K251992) | Savfe Co. , Ltd. | 2026-02-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DORNIER EPOS ULTRA (P000048) | Dornier Medtech America, Inc. | 2002-01-15 |
| DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE (P840008/S069) | Dornier Medtech America, Inc. | 1999-09-02 |
| DORNIER LITHOTRIPTER-DOLI S AND COMPACT DELTA (P840008/S067) | Dornier Medtech America, Inc. | 1999-03-12 |
| UROWAVE (P970044/S003) | Dornier Medtech America, Inc. | 1999-03-12 |
| DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE/TRANSPORTABLE (P840008/S068) | Dornier Medtech America, Inc. | 1999-02-26 |
| DORNIER COMPACT DELTA LITHOTRIPTER (P840008/S066) | Dornier Medtech America, Inc. | 1998-08-21 |
| DORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM (P970044/S002) | Dornier Medtech America, Inc. | 1998-07-10 |
| DORNIER COMPACT DELTA (P840008/S065) | Dornier Medtech America, Inc. | 1998-07-07 |