(57 days)
Not Found
No
The summary describes a remote-controlled radiology table, collimator, and spot film device, which are mechanical and imaging components, with no mention of AI or ML capabilities.
No
The device is described as a remote-controlled radiology table, collimator, and spot film device, used for radiology and fluoroscopy investigations, which are diagnostic imaging procedures rather than therapeutic interventions.
Yes
The device is indicated for "radiology and fluoroscopy investigations," which are procedures used to diagnose medical conditions through imaging.
No
The device description explicitly states it is a "Remote controlled radiology table, collimator and spot film device," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "radiology and fluoroscopy investigations". These are imaging procedures performed on a patient's body, not tests performed on samples taken from the body (which is the core of IVD).
- Device Description: The device is described as a "Remote controlled radiology table, collimator and spot film device". These are components of an X-ray imaging system, not devices used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the APOLLO device, as described, falls under the category of medical imaging equipment rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Remote controlled radiology table, collimator and spot film device.
The indication for use of the APOLLO is: radiology and fluoroscopy investigations when installed in conjunction with adequate image intensifier, image acquisition systems, X-ray generators and X-ray tubes.
Product codes (comma separated list FDA assigned to the subject device)
KXJ, IXL, and KPW
Device Description
The equipment is classified as a class II device since it is composed of the following three components: radiological table (CFR892.1980): class I, spot film device (CFR892.1670): class II, X-ray beam limiting device (CFR 892-1610): class II
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1980 Radiologic table.
(a)
Identification. A radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
Image /page/0/Picture/0 description: The image shows a logo for Villa Sistemi Medicali. The logo features a stylized letter 'V' above the company name. The text 'VILLA' is in a larger font size than 'SISTEMI MEDICALI', which is stacked below it.
MAR 2 5 2005
Koso190
Attachment 1 - 510 (k) SUMMARY
510(k) summary for APOLLO
Identification
| Applicant | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan- Italy
Registration Number: 8021091 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | dr. Roberto Daglio – QA Director |
| Telephone (applicant) | + 39 02 48859233 |
| Designated Agent
in the US | Veronica Meredith
Del Medical Imaging
11550 West King Street
Franklin Park
Illinois 60131
Tel. 847-288-7000 |
| Manufacturing site | Villa Sistemi Medicali S.p.A.
Via delle Azalee 3,
20090 BUCCINASCO - Milan - Italy |
Trade name: APOLLO
Common name: APOLLO R/F remote controlled table
Classification:
The equipment is classified as a class II device since it is composed of the following three components:
radiological table (CFR892.1980): class I
spot film device (CFR892.1670): class II
X-ray beam limiting device (CFR 892-1610): class II
1
150190
Substantial equivalent device: the APOLLO is defined as Substantially Equivalent (SE) to the Philips Medical Systems OMNIDIAGNOST ELEVA, manufactured by Philips Medical Systems and cleared by FDA with K032046
The following table compares the APOLI.O and the predicate device
| APOLLO | Philips Omnidiagnost Eleva | |
|---|---|---|
| Intended use | Remote controlled radiology | |
| table, collimator and spot film | ||
| device | Remote controlled radiology | |
| system inclusive of remote | ||
| controlled table, collimator, | ||
| spot film device, image | ||
| intensifier system | ||
| Working height (table | ||
| top center to | ||
| floorplate) | 600 -1400 mm | 840 -1140 mm |
| Table tilt movement | -90° - +90° | -90° - +90° |
| Table tilt speed | 4.5 -6.5°/sec | Variable 2-4.5°/sec |
| Table top suspension | Two sides suspension | Single side (left or right) |
| Table top material | 2379x750 Plastic laminate or | |
| carbon fiber | 2250 x 660 mm carbon fiber | |
| Table top movement | Patient remain stationary | |
| during all scan movments | Patient remain stationary | |
| during all scan movments | ||
| Table top absorption | Plastic: |