ISOREX LS-36
FDA 510(k) clearance K834496 · decided 1984-02-21
Clearance details
- K-number
- K834496
- Device name
- ISOREX LS-36
- Applicant
- Elscint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-08
- Decision date
- 1984-02-21
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- IZI
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Elscint
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 |
|---|---|---|
| 780 nm SPY Portable Handheld Imaging (SPY-PHI) System (K261037) | Stryker Endoscopy | 2026-05-28 |
| SURGIMAGE SIM 1000H Fluorescence Imaging Platform (K253181) | Surgimage Corporation | 2026-05-13 |
| IC-Flow™ Imaging System 2.0 (K243645) | Diagnostic Green GmbH | 2025-09-22 |
| Affirm 800 (K243077) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| Modus IR (K231986) | Synaptive Medical, Inc. | 2024-03-25 |
| EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004) (K234090) | Surgvision GmbH | 2024-03-20 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| SPY Portable Handheld Imaging (SPY-PHI) System (K230727) | Novadaq Technologies Ulc (A Part of Stryker) | 2023-06-05 |
| EXPLORER AIR® II (K222240) | Surgvision GmbH | 2023-02-28 |
| Explorer Air II (K214097) | Surgvision GmbH | 2022-02-25 |
| DIR 800 (K202391) | Aesculap, Inc. | 2021-01-21 |
| Asimov-MKS Imaging System (K192761) | Onlume, Inc. | 2020-01-17 |
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 |